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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 11/14/2025 has/have been considered by the Examiner.
Status of the Claims
Claims 6-7, 9, 11-12, and 18-20 are cancelled. Claims 21-28 are newly added. Claims 1-2, 5, 8, 10, and 13-17 are currently amended. Claims 1-5, 8, 10, 13-17, and 21-28 are currently pending. Claims 1-5, 8, 10, 13-17, and 21-27 are currently rejected. Claim 28 is objected to.
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/13/2026, with respect to the rejection(s) of claim(s) 1, 16, and the associated dependent claims under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection for claim 16 is made in view of a different interpretation of the prior art.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “annular channel” (claim 16) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the instant specification does not provide support for “an annular channel” as claimed in claim 16.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-17 and 21-22 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The “annular channel” introduced into claim 16 as of the claim set of 02/13/2026 is not described in the specification. Examiner notes that the specification provides support for an arcuate channel (see [0039] and fig. 4), which could be interpreted as being shaped as a portion of a ring, but fails to describe or show a full annular channel, making a full ring shape that “surrounds the central working channel” as claimed.
Dependent claims 21-22 are rejected at least for depending, directly or indirectly, on a claim rejected under 112a since claims inherit the deficiencies of those claims on which they depend.
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.
Claims 1-5, 8, 10, 13-17, and 21-22, and 24-27 are 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 1 recites the limitation “expanding a first expandable member at a distal portion of the first medical device so that it abuts a wall of the body lumen”. In this limitation, the term “it” is unclear, as this term could refer to the first expandable member, the distal portion, or the first medical device, any which could abut a wall of the body lumen. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation. Please amend the term “it” to recite the specific structure which abuts a wall of the body lumen.
Claim 1 recites the limitation “the second expandable member removes material” in the second to last line, line 15. This limitation is unclear because “material” is already introduced in line 1 of claim 1. It is thus unclear whether “material” in line 15 refers back to the “material” introduced in line 1 or is meant to introduce new, separate material. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 16 recites the limitation “wherein a flow of fluid through the fluid exit channel causes rotation of the cap disperses fluid radially-outward from the first medical device in a plurality of directions” in lines 12-14, the last three lines. This limitation is unclear, since “wherein a flow of fluid…causes rotation of the cap disperses fluid” does not clearly associate the fluid dispersion with either the flow of fluid or the rotation of the cap. This limitation could be interpreted to mean that the flow of fluid both causes rotation and disperses fluid, in which case “and” should be added prior to “disperses fluid”. Alternatively, this limitation could be interpreted to mean that the rotation of the cap is what disperses fluid, in which case this limitation could more clearly recite “…causes rotation of the cap, the rotation of the cap dispers[[es]]ing fluid radially-outward…” or “…causes rotation of the cap which disperses fluid radially-outward…”. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 24 recites the limitation “a material” in line 2. The limitation “material” was already introduced in claim 23, from which claim 24 depends. It is thus unclear whether “material” in claim 24 refers back to the “material” introduced in claim 23, or is meant to introduce a new, separate material. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 25 recites the limitation “an opening” on lines 1-2 and “the opening” on line 2. The limitation “an opening” was already introduced in claim 23 line 7, from which claim 25 depends. It is thus unclear whether “an opening” in claim 25 refers back to the “opening” introduced in claim 23, or is meant to introduce a new, separate material. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 26 recites the limitation “a first shaft” on line 2 and “a second shaft” on lines 2-3. The limitation “a shaft” was already introduced in claim 25 line 2, from which claim 26 depends. It is thus unclear whether either one of the “first shaft” or “second shaft” in claim 26 is meant to refer back to the “shaft” introduced in claim 25, or whether both the “first shaft” and “second shaft” are meant to introduce new, separate shafts, both distinct from the “shaft” in claim 25. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 26 recites the limitation “the opening” in line 3. Claim 27 recites the limitation “the opening” in line 1. Since both claims 26 and 27 depend directly or indirectly on claim 25, it is unclear whether “the opening” in claims 26 and 27 refers back to “an opening” as introduced in claim 25 or “an opening” as previously introduced in claim 23, upon which all claims 25-27 depend. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Dependent claims 2-5, 8, 10, 13-15, 17, 21-22, and 26-27 are rejected at least for depending, directly or indirectly, on a claim rejected under 112b since claims inherit the deficiencies of those claims on which they depend.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 23 and 25-27 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gerrans et al (US-20120259215-A1; hereafter Gerrans).
Regarding claim 23, Gerrans, in the art of balloon catheters, discloses a method for removing material from a body lumen ([0081]), the method comprising:
positioning a medical device (catheter assembly 21, fig. 1, [0055]) within the body lumen ([0063] assembly is first inserted into a bodily cavity 60);
expanding a proximal expandable member (first balloon 28, fig. 3a-d, [0063] proximal balloon is inflated) of the medical device;
expanding a distal expandable member (second balloon 30, fig. 3a-d, [0067] distal balloon is inflated) of the medical device; and
delivering fluid from an opening (proximal lumen of inner catheter 26, fig. 3a-d, [0060]) in the medical device into a gap (lumen portion of inner catheter 26 between first balloon 28 and second balloon 30) between the proximal expandable member and the distal expandable member ([0060] inner catheter (26) may have a number of lumens therein, including the lumen (40) for communicating air to the opening (42) and into the second balloon (30) for inflation) (Examiner notes that since the fluid must be delivered to the second balloon 30, .
wherein the fluid contacts and exerts a pressure on the distal expandable member, thereby causing the distal expandable member to move distally relative to the proximal expandable member ([0060] inner catheter (26) may have a number of lumens therein, including the lumen (40) for communicating air to the opening (42) and into the second balloon (30) for inflation) (Examiner notes that the air would cause portions of the second balloon to move distally relative to the proximal expandable member during expansion, as shown in figs. 3a-3d).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Tomari to include a second expandable member as taught by Gerrans since both references deal with balloon catheters. One would have been motivated to make the modification because using the second expandable member distally located to the first expandable member as taught by Gerrans [0079], allows targeted treatment of a region of a body lumen which allows concentrated treatment fluid to be retained in the vicinity of the target site. This targeted treatment may allow more successful treatment of the targeted region and minimize potential damage to healthy tissues that may arise from application of treatment fluids.
Regarding claim 25, Gerrans discloses the method of claim 23, as described above. Gerrans further discloses wherein the fluid is delivered through an opening (see 112b interpretation above) (opening 55, fig. 3c, [0059]) in a shaft (outer catheter 24, fig. 3a, [0081]) of the medical device, wherein the opening is distal to the proximal expandable member and proximal of the distal expandable member (see fig. 3c).
Regarding claim 26, Gerrans discloses the method of claim 25, as described above. Gerrans further discloses wherein the proximal expandable member (first balloon 28, fig. 3a-d) is coupled to a first shaft (see 112b interpretation) (outer shaft 24, fig. 3a-d, [0058]), wherein the distal expandable member (second balloon 30, fig. 3a-d) is coupled to a second shaft (inner shaft 26, fig. 3a-d, [0058]) (see 112b interpretation above), and wherein the opening (see 112b interpretation above) (opening 55) is formed in the first shaft (24) (see fig. 3c and [0059] the outer catheter (24) has a lumen (45) that leads to an opening (55) for delivering a therapeutic and/or diagnostic agent).
Regarding claim 27, Gerrans discloses the method of claim 26, as described above.
Gerrans discloses the claimed invention except for wherein the opening is formed in a distalmost face of the first shaft. It would have been obvious to arrange the opening 55 taught by Gerrans in the distalmost face of the first shaft 24 of Gerrans since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). By making this alteration, the device would be better balanced and delivery of fluid through the opening 55 would be less likely to cause unexpected torquing of the medical device. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-17 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tomari et al (WO 2021085537 A1; hereafter Tomari) in view of Larson et al (US 20180161552 A1; hereafter Larson) and further in view of O’Day et al (US 9314589 B2; hereafter O’Day). Note that text references are made to the Espacenet translation of Tomari was provided with the previous Office Action.
Regarding claim 16, Tomari discloses a method for removing material from a body lumen of a pancreaticobiliary system ([0016] foreign body removal balloon catheter 100 shown in FIG. 1), the method comprising:
positioning a first medical device (balloon catheter 100, fig. 1, [0016]) within the body lumen ([0020] imaging ring 250 is used to confirm the position of the distal end of the catheter tube 200 by X-ray imaging when the distal end is inserted into the body, thereby making it possible to confirm the position of the balloon 300);
expanding an expandable member (balloon 300, [0016], fig. 6) at a distal portion of the first medical device (100) (fig. 6 shows balloon 300 at a distal portion of first medical device 100) from a retracted state to an expanded state ([0025] balloon 300 is expanded by fluid delivered to the inside of balloon 300), wherein the expandable member (300) abuts the body lumen in the expanded state (see fig. 6 which shows that balloon 300 abuts the wall of bile duct 830 when expanded; also note [0055]-[0056] which describes the inflated balloon 300 pushing gallstone 850 out of the bile duct 830, as shown in fig. 6; Examiner notes that in order to reliably push the gallstone out of the bile duct, the balloon must fill the bile duct as shown in fig. 6.); and
providing fluid to a fluid lumen ([0024] contrast medium lumen 240 is formed inside the catheter tube 200, see fig. 3) of the first medical device (100), wherein the fluid lumen (240) is a separate lumen from a central working channel (guide wire lumen 230, fig. 3, [0024]) of the first medical device (100), wherein the fluid lumen (240) is fluidly coupled to a channel (branch tube 500a, [0037] As shown in Figure 5…each of the lumens 220 to 240 inside the large diameter portion 215 is connected to each of the branch tubes 500a to 500c).
Tomari is silent to wherein the expandable member abuts the body lumen in the expanded state.
Larson, in the art of balloon catheters, teaches wherein the expandable member (first balloon 18, fig. 7, [0094]) abuts the body lumen in the expanded state ([0094] first balloon 18 and the second balloon 20 inflated to an expanded configuration whereby they may form a tight, circumferential seal against the inner surface of the body lumen 11).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the expandable member 300 of Tomari to form a tight seal against the inner surface of the body lumen as taught by Larson since both references deal with balloon catheters and fluid delivery therethrough. One would have been motivated to make the modification because having a tight seal between the expandable member 300 and the inside of the body lumen better ensures that the expandable member 300 of Tomari is able to perform the disclosed function of pushing gallstones through the bile duct. If the expandable member 300 of Tomari did not seal with the wall of the bile duct, then gallstones may slip past the expandable member as it is advanced through the bile duct.
Tomari modified by Larson is silent to providing fluid to a fluid lumen of the first medical device to cause rotation of a cap at a distal end of the first medical device and disperse fluid radially-outward from the first medical device in a plurality of directions.
O’Day, in the art of catheters for treating an intravascular site in a patient, teaches providing fluid to a fluid lumen (fluid lumen 32, fig. 1, col. 3 ln. 10-28 elongate catheter body 24 includes an inner surface 30 defining a longitudinally extending fluid lumen 32) of the first medical device (thrombolysis catheter 22, fig. 1, col. 2 ln. 60-66), wherein the annular channel is coupled to a fluid exit channel (spray orifices 40, fig. 1, col. 5 ln. 1-11) having an opening in an outer surface of a cap (spray segment 28, fig. 1, col. 5 ln. 7-23; see opening of fluid exit channels 40 on outer surface of cap 28 in fig. 2/3) at a distal end of the first medical device (see fig. 1 which shows that cap/spray segment 28 is located at a distal end of the catheter 22), wherein a flow of fluid through the fluid exit channel causes rotation of the cap (col. 5 ln. 1-23, supplying fluid through catheter body 24 and through spray orifices 40 causes a torque around longitudinal axis A1 as shown in fig. 2, thus causing cap/spray segment 28 to rotate) disperses (see 112b interpretation above) fluid radially-outward from the first medical device in a plurality of directions (see fig. 2 which shows radially-outward dispersion of fluid in a plurality of directions; col. 3 ln. 29-32 “Elongate catheter body 24 may further define a plurality of spray orifices 40 formed in body wall 34 within spray segment 28 and fluidly communicating between inner surface 30 and outer surface 29”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Tomari modified by Larson to include the fluid supplied rotation of a cap taught by O’Day since all three references deal with fluid delivery through catheters and Larson also teaches multiple apertures for fluid delivery. One would have been motivated to make the modification because, as noted by O’Day in col. 5 ln. 7-28, the rotational motion of cap/spray segment 28 can cause the catheter body to contact and dislodge material such as thrombus material, thus further facilitating treatment of the thrombus. Thus, it would have been obvious to use the cap/spray segment 28 of O’Day to assist in dislodging the gallstones of Tomari modified by Larson and thus increase thoroughness of fluid application and better facilitate movement of gallstones out of the bile duct.
Tomari as modified discloses the claimed invention except for wherein the channel is an annular channel that surrounds the central working channel. Tomari [0033] recites “The cross-sectional view of the catheter tube 200 in FIG. 3 is an example, and the cross-sectional shape of each of the lumens 220 to 240 is not limited to the shape shown in FIG.” It would have been obvious to one having ordinary skill in the art at the time the invention was made to alter the channel/branch 500a and fluid lumen 220 to be annular and surround the central working channel since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). By making this alteration, the device would be better balanced and delivery of fluid through the fluid lumen would be less likely to unevenly stretch the exterior of the medical device. Additionally, this modification suits the combination of Tomari and O’Day since O’Day shows exit lumens 40 located around the entire circumference of the catheter, such that an annular fluid lumen would better provide fluid to all exit openings. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Regarding claim 17, Tomari modified by Larson and O’Day discloses the method of claim 16, as described above, including wherein the fluid exit channel (O’Day: orifices 40) extends to a radially-outermost portion of the cap (O’Day: 28), relative to a central longitudinal axis (O’Day: longitudinal axis A1 as shown in fig. 2) of the first medical device (O’Day: thrombolysis catheter 22, fig. 1) (O’Day: see fig. 2 which shows that orifices 40 extend to the radially-outermost portion of the cap 28).
Regarding claim 22, Tomari modified by Larson and O’Day discloses the method of claim 16, as described above. Tomari further discloses wherein the fluid lumen (balloon lumen 220, [0025]) has a distalmost end ([0025] The fluid communication port is an opening provided in the small diameter portion 210 of the catheter tube 200 that opens into the interior of the balloon 300) that is proximal of a distalmost end (guidewire insertion hole 231, fig. 1, [0026]) of the central working channel (guidewire lumen 230, fig. 1, [0026] The guidewire lumen 230 passes through the catheter tube 200 from the proximal end to the guidewire insertion hole 231 at the distal end) (see fig. 1 which shows that balloon 300, where the fluid lumen 220 ends, is proximal to the distalmost end 231 of the central working channel 230).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tomari modified by Larson and O’Day, as applied to claim 16 above, and further in view of Nelson (US-20090143764-A1; hereafter Nelson).
Regarding claim 21, Tomari as modified discloses the method of claim 16, as described above.
Tomari as modified is silent to wherein the cap is coupled to a shaft of the first medical device via a flange of the shaft.
wherein the cap (guide tube 308, fig. 4d, [0066]) is coupled to a shaft (catheter body 306, fig. 4d, [0066]) of the first medical device via a flange of the shaft (mechanical capture points, [0066] forming mechanical capture points or recesses into which inwardly extending portions of the body may extend as shown in Figure 4D.)
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the cap of Tomari as modified to include the flange for attachment as taught by Nelson since Nelson also deals with catheters. One would have been motivated to make the modification because the flange of Nelson ensures firm attachment of the cap and shaft.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Gerrans in view of Tomari.
Regarding claim 24, Gerrans discloses the method of claim 23, as described above.
Gerrans is silent to using the distal expandable member to push a material.
Tomari, in the art of balloon catheters, teaches further comprising: using the distal expandable member (balloon 300, fig. 7a) to push a material (see 112b interpretation above) (gallstone 850, fig. 7a) that is distal of the distal expandable member in a distal direction ([0056] distal end of the inflated balloon 300 pushes the gallstone 850 out of the bile duct 830 from the duodenal papilla 840, thereby removing it).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Gerrans to include the distal movement of the distal balloon of Tomari to push a material in a distal direction since both references deal with balloon catheters for removing material from a body lumen. One would have been motivated to make the modification because this additional step could allow the method of Gerrans to be practiced, if necessary, in such a way that an obstruction is pushed out of an area of interest as well as dissolving material which might not be so easily pushed into a larger orifice.
Allowable Subject Matter
Claims 1-5, 8, 10, 13-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 28 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 1 as amended recites the limitation:
"wherein a pressure of the fluid between the first expandable member and the second expandable member causes the second expandable member to move distally relative to the first expandable member, wherein such distal movement of the second expandable member removes material from the body lumen"
Similarly, claim 28 recites the limitation (in combination with independent claim 23):
“delivering fluid from an opening in the medical device into a gap between the proximal expandable member and the distal expandable member, wherein the fluid contacts and exerts a pressure on the distal expandable member, thereby causing the distal expandable member to move distally relative to the proximal expandable member.” (claim 23)
“wherein the fluid contacts the proximal expandable member, the distal expandable member, and a wall of the body lumen.” (dependent claim 28)
Horowitz (US-10172634-B1) teaches moving two balloons relative to each other during removal of material from within the body.
Gerrans (US-20120259215-A1) teaches, in [0082] and [0024], for example, "increasing the fluid pressure within the chamber by moving at least one of the first and second balloons toward the other of the first and second balloons" ([0024]). Gerrans shows the progression in fig. 5a-d.
Neither Horowitz nor Gerrans teaches the relative movement of two balloons as part of a method in which the movement is caused by the delivery of fluid and subsequent increase in pressure within a body lumen, the fluid pressure acting on an outer face of one of the balloons, causing two balloons to move relative to one another.
None of the prior art teaches all limitations of claim 1 or 28 together, or separately in such a way that it would make sense to combine the references to arrive at the claimed limitation of a method step of delivery fluid into a body lumen between two balloons causing the fluid pressure between the two balloons to increase and thus cause the balloons to move relative to each other. As such, one of ordinary skill in the art would not have been able to combine the prior art in such a way as to arrive at the invention of the independent claims.
As claims 2-5, 8, 10, and 13-15 are dependent either directly or indirectly on claim 1, and thus include subject matter which is deemed allowable by Examiner, these claims are also allowable for the reasons outlined above. Claims 1-5, 8, 10, 13-15, and 28 are deemed to contain allowable subject matter.
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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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/19/2026