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
Claims 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/25/2026.
Applicant's election with traverse of Group II: Claims 13-19 in the reply filed on 02/25/2026 is acknowledged. The traversal is on the ground(s) that Examiner did not provide any support with the restriction as well did not provide any evidence supporting the seriousness of the search burden.. This is not found persuasive because Group I: Claims 1-12 has a different design, mode of operation then Group II: Claims 13-19 such that Group I contains cryogenic agent injection ports which are not seen in Group II such that Group II does not have the injection ports such that the cryogenic agent in Group II does not have to be sprayed into the balloon and could be filled into the chamber in many different ways such that it will create a search burden. Regarding Groups I and Group III: Claim 20, the process for using the product as claimed can be practived with another materially different product such that the process III, can be used with a product that does not contain a dual lobed balloon, a different method of ablation other than electromagnetic or cryogenic, a different cooling region shape other than a mulitstar arm or three-star arm, ablation not using electrodes and not requiring an insulated balloon. Therefore, will create a search burden. Regarding Groups II & Group III, the process for using the product as claimed can be practived with another materially different product such that the process III, can be used with a product that does not contain a dual lobed balloon, a different method of ablation other than electromagnetic or cryogenic, a different cooling region shape other than a mulitstar arm or three-star arm, ablation not using electrodes and not requiring an insulated balloon. Therefore, creates a search burden
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The use “for” in the claim is seen as intended use and therefore is given limited patentable weight and the prior art used below would be capable of performing the “for” function based on structure.
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 13-14 is rejected under 35 U.S.C 103 as being unpatentable over Govari et al. (US 20230380890) herein referred to as Govari, in view of Arevalos et al. (US 20190374254) herein referred to as Arevalos.
Regarding Claim 13, Govari discloses an apparatus (Figure 1) comprising: an elongate tool body comprising at least one lumen (Figure 1, 22) and a distal portion (Figure 1, 66 & 40); the elongate tool body comprising: a distal puncturing tip for puncturing an interatrial septum of a heart of a patient to create an opening (Paragraph [0026]; wherein insertion of guidewire, through the vasculature system of patient, into a right atrium of heart, (ii) puncturing a hole (also referred to herein as a transseptal hole) in a septum between right atrium and left atrium); and an inflatable balloon configured to be inflated via the lumen of the elongate tool body (Figure 1, 40; Paragraph [0026]; wherein the distal-end assembly is a balloon), wherein the inflatable balloon comprises: a distal outer surface configured for contacting the interatrial septum (Paragraph [0026]; wherein moving the balloon along guidewire into the intended location in left atrium will allow for the distal outer surface to contact the interatrial septum.); an ablation region of the distal outer surface of the inflatable balloon for ablating the interatrial septum when the inflatable balloon receives the ablation energy (Paragraph [0026]; wherein the balloon contains multiple ablation electrodes disposed on the outer surface of the balloon) and wherein the inflatable balloon is configured to advance through the opening (Paragraph [0026]; wherein moving the balloon along guidewire into the intended location in left atrium will allow for the distal outer surface to contact the interatrial septum.). However, Govari does not explicitly disclose wherein the ablation region is disposed on the distal outer surface of the inflatable balloon in a manner that the ablation region creates a multi cuspid ablation pattern when the inflatable balloon receives the ablation energy and the inflation balloon is configured to dilate the opening causing tissue to tear along the multi cuspid ablation pattern.
Arevalos discloses an apparatus (Figure 1) wherein the ablation region is disposed on the distal outer surface of the inflatable balloon in a manner that the ablation region creates a multi cuspid ablation pattern when the inflatable balloon receives the ablation energy (Paragraph [0230]; wherein the outside surface of the balloon uses cryoablation to freeze target portion of the septum such that it would create a multi cuspid pattern such that it is freezing the septum at different points) and the inflation balloon is configured to dilate the opening causing tissue to tear along the multi cuspid ablation pattern (Paragraph [0146]; wherein the balloon is subsequently inflated and pulled proximally thereby it will dilate before tearing the septum and opening an interatrial aperture). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Govari to include the inflatable balloon taught by Arevalos. The motivation being it allows for the resultant tissue flaps to remain in place to be fused back together (Arevalos, Paragraph [0146]).
Regarding Claim 14, Govari in view of Arevalos disclose the apparatus of claim 13. Arevalos also discloses wherein the inflatable balloon comprises a dual-lobe balloon having a distal lobe and a proximal lobe with a waist in between the distal lobe and the proximal lobe (Paragraph [0004];Figure 9), and wherein the waist is configured for dilating the opening causing the tissue to tear along the multi cuspid ablation pattern (Paragraph [0004]; wherein the balloon can be dog bone or dumbbell shaped which is seen as a dual lobe balloon wherein the middle portion is smaller than the two outer portions creating a waist and the balloon is configured to expand therefore dilate the septum such that looking at figure 9, the waist is what would dilate the septum opening). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflation balloon taught by Govari in view of Arevalos to include the teachings of the inflatable balloon taught by Arevalos. The motivation being to sandwich the septum and allow for tissue stabilization (Arevalos, Paragraph [0004]).
Claims 15 is rejected under 35 U.S.C 103 as being unpatentable over Govari and Arevalos in further view of Wang et al. (US 20220233827) herein referred to as Wang
Regarding Claim 15, Govari in view of Arevalos disclose the apparatus of claim 14. However, Govari in view of Arevalos does not explicitly disclose wherein a diameter of the distal lobe and the proximal lobe is 15–30mm, and wherein a diameter of the waist is 5–15mm.
Wang discloses an apparatus (Figure 2) wherein a diameter of the distal lobe and the proximal lobe is 15–30mm (Paragraph [0073]; wherein the diameter of the balloon can range from 2 millimeters to about 40 millimeters), and wherein a diameter of the waist is 5–15mm (Figure 2; Paragraph [0073]; wherein the diameter of the balloon (D1 & D3) can range from 2 millimeters to about 40 millimeters therefore, the waist (D2) has to be smaller therefore, the waist can be less than 2 millimeters to less than 40 millimeters). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameters of the balloon taught by Govari in view of Arevalos to be within the range taught by Wang. The motivation being to allow for a diameter ratio between the larger and smaller diameters to be determined by clinical dosing needs (Wang, Paragraph [0076]).
Claims 16-17 is rejected under 35 U.S.C 103 as being unpatentable over Govari and Arevalos in view of Perez et al. (US 20220087742) herein referred to as Perez.
Regarding Claim 16, Govari in view of Arevalos disclose the apparatus of claim 13. However, Govari in view of Arevalos does not explicitly disclose wherein the ablation region has a shape of a multi-armed star.
Perez discloses an apparatus (Figure 1) wherein the ablation region has a shape of a multi-armed star (Figure 1; 9; Paragraph [0033]; wherein each branch 9 can have one ablation electrode attached therefore would make a four armed star). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the ablation region taught by Govari in view of Arevalos to be the ablation region taught by Perez. The motivation being to allow for ablation in selected zone of the tissue (Perez, Claim 15).
Regarding claim 17, Govari and Arevalos in further view of Perez disclose the apparatus of claim 16. Perez also discloses wherein the ablation region has a shape of a three-armed star (Paragraph [0017]; wherein the apparatus can contain 2 or more branches such that 3 branches with one ablation electrode on it will create a three-armed star). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the ablation region taught by Govari in view of Arevalos to be the ablation region taught by Perez. The motivation being to allow for ablation in selected zone of the tissue (Perez, Claim 15).
Claim 18 is rejected under 35 U.S.C 103 as being unpatentable over Govari and Arevalos in view of Schuler et al. (US 20250049490) herein referred to as Schuler.
Regarding Claim 18, Govari in view of Arevalos disclose the apparatus of claim 13 wherein: the ablation energy comprises cryogenic energy (Arevalos, Paragraph [0230]). However, Govari in view of Arevalos does not explicitly disclose the inflatable balloon further comprises: an interior chamber for receiving a cryogenic agent; and an insulated region of the distal outer surface of the inflatable balloon for insulating the interatrial septum from cooling from the cryogenic agent.
Schuler discloses an apparatus (Figure 1) the inflatable balloon further comprises: an interior chamber for receiving a cryogenic agent (Paragraph [0095]; wherein inflatable balloon has a cooling chamber for the cryogenic agent); and an insulated region of the distal outer surface of the inflatable balloon for insulating the interatrial septum from cooling from the cryogenic agent (Paragraph [0564]; wherein the whole outer surface of the inflatable balloon is insulated therefore would allow for insulating of the interatrial septum from cooling). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflatable balloon taught by Govari and Arevalos to include the inflatable balloon teachings taught by Schuler. The motivation being cryotherapy may also cause permanent alteration to treated tissue, preventing the treated tissue from propagating or sourcing electrical signals, thereby reducing or eliminating atrial fibrillation (Schuler, Paragraph [0095]).
Claim 19 is rejected under 35 U.S.C 103 as being unpatentable over Govari and Arevalos in view of Falahatpisheh et al. (US 20250143781) herein referred to as Falahatpisheh.
Regarding Claim 19, Govari in view of Arevalos disclose the apparatus of claim 13. However, Govari in view of Arevalos does not explicitly disclose wherein: the ablation energy comprises electromagnetic energy, and the ablation region further comprises one or more electrodes shaped to create the multi cuspid ablation pattern when the one or more electrodes are energized with the ablation energy.
Falahatpisheh discloses an apparatus (Figure 1) wherein: the ablation energy comprises electromagnetic energy (Paragraph [0151]; wherein the ablation energy can comprise electromagnetic energy), and the ablation region further comprises one or more electrodes shaped to create the multi cuspid ablation pattern when the one or more electrodes are energized with the ablation energy (Paragraph [0137]; wherein energy delivery elements are electrodes and the energy can be delivered to the electrodes on device 200 of Figure 1 such that it has a basket shape creating a multi cuspid ablation pattern). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have substituted the ablation energy, cryoablation taught by Govari in view of Arevalos for electromagnetic energy. The motivation being a simple substitution of one know ablation energy, cryogenic for another, electromagnetic to achieve the predictable results of ablating tissue (MPEP 2143 (B)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794