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 .
Response to Amendment
Acknowledgment is made to the amendment received 6/12/2025.
Response to Arguments
Applicant’s arguments with respect to claim 11 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. Previously, claim 11 was rejected under 35 U.S.C. 102(a)(1) as being anticipated by Celermajer. Now, based on amendments to the claim language, claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Celermajer in view of Takahashi.
Claim Objections
Claim 21 is objected to because of the following informalities: Line 1: “The method of claim 11” should read –The device of claim 11--. Appropriate correction is required.
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 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.
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.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Celermajer et al., US 20120259263, herein referred to as “Celermajer”, further in view of Takahashi et al, WO 2019188916, herein referred to as “Takahashi”.
Regarding claim 11, Celermajer discloses a medical device (Figure 3), comprising: an elongate body (Figure 3: dilation catheter 104) defining a major longitudinal axis and having a proximal portion and a distal portion (Figure 3: dilation catheter 104 has a major longitudinal axis and a proximal portion and a distal portion); a balloon coupled to the distal portion (Figure 3: balloon 302), wherein the balloon includes a pair of longitudinally spaced lobes (Figure 3: balloon 302 has two lobes) and a middle portion disposed therebetween ([0056]: “The dilation balloon 302 of FIG. 3 may be shaped with an hour glass type shape where the diameter at the center of the balloon is smaller than the diameter at either end.”), each lobe of the pair of longitudinally spaced lobes having a first diameter and a second diameter (Figure 3: balloon 302 has two lobes), respectively, and the middle portion having a third diameter that is less than both the first diameter and the second diameter ([0056]: “The dilation balloon 302 of FIG. 3 may be shaped with an hour glass type shape where the diameter at the center of the balloon is smaller than the diameter at either end.”); a therapeutic drug coated around an outer surface of the balloon ([0055]: “In other embodiments, the treatment includes delivering a medication or combination of medications to the tissue.” And [0019]: “The balloon features a coating which incorporates at least one anti-proliferative drug or immunosuppressant drug.”), the therapeutic drug being a chemical used to inhibit tissue growth ([0019]: “The balloon features a coating which incorporates at least one anti-proliferative drug or immunosuppressant drug.”); and an ablation element disposed substantially within the balloon and configured to deliver ablation energy to an interior surface of the balloon ([0055]: “In some embodiments, the treatment may include a means for delivering energy to the tissue.” And [0016]), wherein each of a first lobe and a second lobe of the pair of longitudinally spaced lobes are sized and configured to, when inflated and disposed within an atrial shunt (Figure 3), form a shape configured to abut the septal wall from both sides (Figure 3: and [0055]-[0056]) and cause the therapeutic drug to contact at least one side of the atrial septal wall extending from the shunt ([0055]: “The balloon 302 optionally incorporates a means for treating the tissue surrounding the intra-atrial pressure relief opening… In other embodiments, the treatment includes delivering a medication or combination of medications to the tissue.”), wherein the at least one side of the atrial septal wall is within one of the left atrium or the right atrium (Figure 3: right atrium 108 and left atrium 110). Celermajer does not explicitly disclose a device wherein each of a first lobe and a second lobe of the pair of longitudinally spaced lobes are sized and configured to form a wedge shape configured to abut the septal wall from both sides.
However, Takahashi teaches a device (Figure 20B) wherein each of a first lobe and a second lobe of the pair of longitudinally spaced lobes (Figure 20B: high-compliance portion 151 of balloon 150) are sized and configured to form a wedge shape configured to abut the septal wall ([0003] and [0021]) from both sides (Figure 20B: grip portions 153 and [0062]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Celermajer so that the lobes are sized and configured to form a wedge shape configured to abut the septal wall from both sides as taught by Takahashi so that the expansion operation and the gripping operation can be performed simultaneously (Takahashi [0048]).
Regarding claim 12, Celermajer in view of Takahashi discloses the device of Claim 11, and Celermajer further discloses a device wherein the ablation energy is a dose of refrigerant ([0016]).
Regarding claim 21, Celermajer in view of Takahashi discloses the device of Claim 11, and Celermajer further discloses a device wherein the at least one side of the atrial septal wall is a first side of the atrial septal wall (Figure 3: right atrium 108), wherein each of the first lobe and the second lobe of the pair of longitudinally spaced lobes are sized and configured to, when inflated and disposed within the atrial shunt (Figure 3: balloon 302 contacts at least a portion of each side of the atrial septal wall), abut and cause the therapeutic drug to contact a second side of the atrial septal wall extending from the shunt ([0055]: “In other embodiments, the treatment includes delivering a medication or combination of medications to the tissue.” And [0019]: “The balloon features a coating which incorporates at least one anti-proliferative drug or immunosuppressant drug.”), wherein the second side of the atrial septal wall is within the other of the right atrium or the left atrium (Figure 3: left atrium 110).
Claims 13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Celermajer in view of Takahashi, further in view of LaLonde et al., US 20130197499, herein referred to as “LaLonde”.
Regarding claim 13, Celermajer in view of Takahashi discloses the device of claim 12, but does not explicitly disclose a device wherein the ablation element includes a first plurality of spray ports configured to deliver the dose of refrigerant to the interior surface of the balloon.
However, LaLonde teaches a device (Figures 2A-B) wherein the ablation element includes a first plurality of spray ports configured to deliver the dose of refrigerant ([0005] and [0012]: “injecting coolant through a fluid injection element within the first portion, the fluid distribution element guiding coolant toward the interior wall of the first portion”) to the interior surface of the balloon (Figure 2A: fluid injection element 52 and [0033]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Celermajer so that there is a first plurality of spray ports configured to deliver the dose of refrigerant to the interior surface of the balloon as taught by LaLonde to quickly direct the cold coolant to the target area for a more efficient use of coolant (LaLonde [0030]).
Regarding claim 15, Celermajer in view of Takahashi and LaLonde discloses the device of claim 13, and Celermajer further discloses a device wherein the pair of longitudinally spaced lobes are sized and configured to, when inflated ([0056]: “The dilation balloon 302 of FIG. 3 may be shaped with an hour glass type shape where the diameter at the center of the balloon is smaller than the diameter at either end. ”), abut and thermally isolate an atrial septum from blood flowing within a left atrium and a right atrium when the balloon is disposed within an atrial shunt (Figure 3: middle part of balloon 302 is in contact with both sides of atrial septum 100, thereby isolating right atrium 108 and left atrium 110).
Regarding claim 16, Celermajer in view of Takahashi and LaLonde discloses the device of claim 15, and LaLonde further discloses a device wherein the first plurality of spray ports is angled in a direction substantially orthogonal to the major longitudinal axis (Figure 2A: fluid injection element 52 is orthogonal to the major longitudinal axis defined by shaft 38).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Celermajer so that the first plurality of spray ports is angled in a direction substantially orthogonal to the major longitudinal axis as taught by LaLonde to quickly direct the cold coolant to the target area for a more efficient use of coolant (LaLonde [0030]).
Regarding claim 17, Celermajer in view of Takahashi and LaLonde discloses the device of claim 16, and LaLonde further discloses a device further including a second plurality of spray ports within the middle portion (Figures 2A-B: apertures 54 and [0032]: “Coolant is injected into the first portion 48 of the cooling chamber 40 and directed through the apertures 54 of the membrane 46 and into the second portion 50”) and longitudinal spaced from the first plurality of spray ports (Figure 54: apertures 54 are longitudinally spaced from fluid injection element 52).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Celermajer so there is a second plurality of spray ports as taught by LaLonde to quickly direct the cold coolant to the target area for a more efficient used of coolant (LaLonde [0030]).
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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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794