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 view of the appeal brief filed on 9/30/2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794
Response to Arguments
Applicant’s arguments, see pages 5-9, filed 9/30/2025, with respect to the rejection of claim 11 under 35 U.S.C. 102(a)(1) as being anticipated by Wang have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a newly found prior art reference, Ben-David. Thus, claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Ben-David.
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, 15, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., CN 111166462, herein referred to as “Wang”, in view of Ben-David et al., US 20210121179, herein referred to as “Ben-David”.
Regarding claim 11, Wang discloses a medical device (Figures 8 and 27), comprising: an elongate body (Figure 8: ostomy device control mechanism 50) defining a major longitudinal axis and having a proximal portion (Figure 8: the part near left superior pulmonary vein 605) and a distal portion (Figure 8: atrial septal ostomy device 20 and Figure 27); the distal portion including an expandable member (Figure 27: support framework 21a), the expandable member including a pair of longitudinally spaced lobes having a first diameter (Figure 27: first positioning portion 213a and second positioning portion 217) and a middle portion having a second diameter less than the first diameter disposed therebetween (Figure 27: strut portion 211); and an ablation element disposed substantially within the middle portion (Figure 27: ablation elements 210e), the ablation element being configured to deliver ablation energy to a shunt in an atrial septal wall when the middle portion of the expandable member is disposed within the shunt (Page 11, 1st full paragraph), wherein a first lobe and a second lobe of the pair of longitudinally spaced lobes are sized and configured to, when inflated, abut and thermally isolate a first side and a second side of the atrial septal wall extending from the shunt (Figure 8 and Figure 27: insulating film 27 and Page 11, 5th paragraph), respectively, from blood flowing within a left atrium and a right atrium from warming the septal wall extending from the shunt being ablated when the expandable member is disposed within the shunt between the left atrium and the right atrium (Page 4, 6th paragraph underneath the heading ‘Detailed Description’ and Page 11, 2nd paragraph), wherein the first side of the atrial septal wall is within one of the left atrium or the right atrium and the second side of the atrial septal wall is within the other of the right atrium or the left atrium (Page 11, 5th paragraph). Wang does not explicitly disclose a device wherein the expandable member is a balloon.
However, Ben-David teaches a device (Figure 15A) wherein the expandable member is a balloon (Figure 15A: balloon catheter 60).
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 Wang so that the expandable member is a balloon as taught by Ben-David so that the device may be pre-formed to have various shapes and sizes upon inflation of the balloon catheter to achieve the desired adjustment of the first end region, second end region, and middle region of the passage device (Ben-David [0070]).
Regarding claim 15, Wang in view of Ben-David discloses the device of claim 11, and Wang further discloses a device wherein the ablation element is configured to deliver radio frequency ablation energy (Figure 27: ablation elements 210e and Page 13, last four paragraphs – Page 14, first two paragraphs [list of six options]).
Regarding claim 23, Wang in view of Ben-David discloses the device of claim 11, and Wang further discloses a device wherein the first and second sides of the atrial septum are outside a circumference of the shunt (Figure 8 and Page 11, 5th paragraph).
Regarding claim 24, Wang in view of Ben-David discloses the device of claim 11, and Wang further discloses a device wherein the first lobe and the second lobe (Figure 27: first positioning portion 213a and second positioning portion 217) are configured to, when inflated, form a wedge shape configured to trap the septal wall from both the first side of the septal wall and the second side of the septal wall (Page 11, 5th paragraph) and isolate a corresponding area of the septal wall from blood flowing in the right atrium and blood flowing in the left atrium, wherein the corresponding area of the septal wall that is isolated extends from a circumference of the shunt to the diameter of the wedge shape trapping the septal wall (Page 11, 1st full paragraph).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Ben-David, further in view of Wang et al., WO 2019179447, herein referred to as “Wang 2”.
Regarding claim 12, Wang in view of Ben-David discloses the device of claim 11, but does not explicitly disclose a device wherein the ablation element includes a first plurality of spray ports configured to deliver refrigerant to the middle portion.
However, Wang 2 discloses a medical device wherein the ablation element (Figure 21: electrode assembly 130, electrode group 130a, electrode group 130b, and electrodes 131) includes a first plurality of spray ports (Figure 21: small hole 118) configured to deliver refrigerant to the middle portion ([0104]).
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 Wang so that it includes a first plurality of spray ports configured to deliver refrigerant to the middle portion as taught by Wang 2 to avoid thrombus formation (Wang 2 [0104]).
Regarding claim 13, Wang in view of Ben-David and Wang 2 discloses the device of claim 12, and Wang 2 further discloses a medical device wherein the first plurality of spray ports (Figure 21: small hole 118) is angled in a direction orthogonal to the major longitudinal axis (Figure 21: small hole 118 is in a direction orthogonal to the major longitudinal axis and [0104]).
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 Wang so that it includes a first plurality of spray ports angled in a direction orthogonal to the major longitudinal axis as taught by Wang 2 to avoid thrombus formation (Wang 2 [0104]).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Ben-David and Wang 2, further in view of LaLonde et al., US 20130197499, herein referred to as “LaLonde”.
Regarding claim 14, Wang in view of Ben-David and Wang 2 discloses the device of claim 13, but does not explicitly disclose a device further including a second plurality of spray ports within the middle portion and longitudinally spaced from the first plurality of spray ports.
However, LaLonde teaches a device (Figure 3) including a second plurality of spray ports (Figure 3: fluid injection element 52) within the middle portion and longitudinally spaced from the first plurality of spray ports (Figure 3: fluid injection element 52 is in the middle of balloon 30 and has many ports that are longitudinally spaced from each other).
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 Wang 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794