DETAILED ACTION
This action is pursuant to claims filed on November 7, 2025. Claims 1-4, 7, 14, 21, 26-30, and 32-35 are pending. Claims 5-6, 8-13, 15-20, 22-25, 31 and 36 are canceled. A first action on the merits of claims 1-4, 7, 14, 21, 26-30, and 32-35 is as follows.
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 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.
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 26, 28, and 32-35 are 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.
In regards to claim 26, the claim recites that the self-expanding mesh assembly includes a balloon assembly. However, the embodiment of Figs. 5-6, and the written part of the specification, [0036]-[0041], do not disclose any balloon assembly that works in conjunction with the self-expanding mesh assembly (400). The balloon assembly is directed to the embodiment of Figs. 1-2 and the embodiment of Figs. 3-4. Although paragraph [0046] explains that any technical feature can be combined, pull wire and balloon assembly are art recognized equivalence for deployment. As shown in Figs. 5-6, it is unclear how a balloon assembly will be incorporated into the embodiment so that the pull wire which is attached to a specific portion (i.e. an intersection of the mesh in the base portion) of the mesh assembly and the balloon assembly will work in tandem to deploy and expand the self-expanding mesh assembly.
Accordingly, claims 28, and 32-35 are rejected by virtue of its dependency of claim 26.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4, 7, 14, 21, 26-30 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Gelbart et al. (hereinafter ‘Gelbart’, U.S. PGPub. No. 2016/0008062), and further in view of Tah et al. (hereinafter ‘Tah’, U.S. PGPub. No. 2015/0119895).
In regard to independent claims 1 & 26 and claim 4, 7, 11, 21, 32-33 & 34, Gelbart discloses an apparatus (an intra-cardiac mapping system as shown in use in Figs. 1, 5 & 6), comprising:
a medical-mapping and ablation device (device of Fig. 1 is for sensing and ablation, [0027]), including:
an elongated electrode-support assembly (a catheter 60) having a distal section (distal portion of the catheter 60) configured to be maneuverable, at least in part, into, and along, a confined space of a patient ([0027]-[0028]: catheter shaft is configured for insertion into the patient’s vasculature and the heart as shown in Fig. 1);
spaced-apart electrodes (Fig. 2 illustrate exemplary three elements 10a-10c can be used as ablation electrodes and for mapping, [0034], [0038]) being configured to be selectively movable between a storage position and a deployment position (the elements 10 are closely spaced within the catheter 60 and are configured to be spared apart when the mesh 7 is deployed out of the catheter 60 as shown in Fig. 3A and deployed position 3B, respectively), wherein a first one or more of the space-apart electrodes are configured for medical-mapping and at least a second one or more of the spaced apart electrodes are configured for ablation, each spaced-apart electrode is connected to a respective wire routed through the elongated electrode-support assembly (elements 10 are used for temperature sensing, mapping and ablation, [0038]-[0039]: the electrical system of Fig. 5 is configured to select between ablation mode and mapping mode; therefore, one element 10 can be configured to ablation while the other element 10 can be configured for mapping; each of the coiled portion of element 10 are connected to its corresponding lead 13 as labeled in Fig. 4 & 5);
a self-expanding mesh assembly (self-expanding mesh 7 is formed from nitinol, [0035]-[0036]) supporting the spaced-apart electrodes (elements 10 coiled around/mounted to the wires 25 and 26 as best shown in Fig. 4), the mesh assembly comprising a plurality of nitinol mesh wires arranged in a lattice pattern (mesh 7 is formed from cross wires 25 and 26 which are nitinol wires) and having a base portion at a proximal end thereof (proximal portion of the mesh 7 that is closer to the shaft of catheter 60), the mesh assembly configured to be positioned within a lumen of the elongated electrode-support assembly to be contractible for selective movement of the spaced-apart electrodes from the deployment position toward the storage position (Fig. 3A illustrates the mesh 7 being disposed in the lumen of catheter 60 and being deployed in Fig. 3B; note that the spacing between the elements 10 vary as the mesh expands and contracts depending upon its storage or deployed position),
wherein the mesh wires configured to cover an entirety of a heart chamber in the deployment position (Fig. 1 illustrates the mesh 7 formed from wires 25 and 26 covering the left atrium);
a balloon assembly internally attached to the mesh assembly and configured to expand in response to the urged movement of the mesh assembly between the storage position within the lumen of the elongate electrode-support assembly and the deployment position outside the lumen of the elongated electrode-support assembly in response to application of the user-initiated push to the pull wire ([0035]: the balloon can be used to expand the mesh 7; the expansion of the balloon has to be initiated by delivering fluid or air which is a form of a user-initiated mechanism; since the ballon can be removed independently from the mesh 7 to avoid blocking the flow of blood, the examiner notes that there is an additional user-initiated mechanism to remove it from the mesh 7 which; in light of the 112a rejection above, the examiner notes that there is no support in the specification for expanding the balloon assembly when the pull wire is pushed, therefore, as long as the balloon assembly can be incorporated into the mesh assembly, it meets the claim limitation).
wherein the mesh assembly is configured to maintain contact with tissue of the heart chamber for electrical mapping (element 10 on the mesh 7 as best shown in Fig. 4 can be used for mapping and ablation and the mesh 7 is in contact with or close to the atrial wall during the cardiac cycle, [0036]-[0041]), the mesh assembly having sufficient structural rigidity to resist deformation when positioned against the tissue of the heart chamber (longitudinal wires of the mesh 7 are stiffer than the cross wires 26 to allow for self-expansion or sufficient structural rigidity for positioning against the atrial wall during cardiac cycle, [0035]-[0036]).
Gelbart fails to specifically disclose how the mesh assembly is deployed through the lumen of the elongated electrode-support assembly using a pull-wire connected to an intersection of the plurality of wires in the base portion of the mesh assembly spaced from the proximal end.
Tah teaches a medical device (device 10 in Fig. 7) including a handle (handle assembly 12) and a sheath (sheath 98b) coupled to the handle. The handle comprising actuation unit (first button unit 54) configured to connect with a basket assembly (122b) via a pull wire (stem 184) such that a user-initiation of the actuation unit pushes the pull wire to distally advance the basket assembly to extend out of a distal end of the sheath and pulls the pull wire to proximally moving the basket assembly to a compressed state in a storage position within the lumen of the sheath ([0078]). Instead of retracting the sheath to expose the mesh assembly for self-expansion, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nitinol mesh wires of the mesh assembly of Gelbart and incorporate a pull wire and its actuation mechanism as taught by Tah so that the mesh assembly can be controllably advanced and retracted into the sheath as claimed ([0078]). Doing so is merely one of two possibilities from which one of ordinary skill in the art would select to expose the mesh assembly from the sheath.
Tah further discloses that the pull wire is attached to the proximal end of the basket assembly. However, it would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention attach the pull wire along the mesh assembly, since applicant has not disclosed that providing the pull wire along the base portion of the mesh assembly spaced from the proximal end solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with when the pull wire is attached in any of the two positions.
In regards to claim 2, Gelbart/Tah combination discloses wherein the spaced-apart electrodes are configured to be selectively movable between the storage position located proximate to the elongated electrode support assembly (see Fig. 3A) and the deployment position located distally from the elongated electrode support assembly (see Fig. 3B).
In regards to claim 3, Gelbart/Tah combination further discloses the spaced-apart electrodes are configured to be selectively movable, at least in part, radially from the elongated electrode-support assembly (spacing of elements 10 transitioning from 3A to Fig. 3B); and the spaced-apart electrodes are configured to be selectively movable, at least in part, radially toward the elongated electrode-support assembly (spacing of elements 10 transitioning from 3B to Fig. 3A).
In regard to claims 27-28, Gelbart/Tah combination further discloses wherein the pull wire extends proximally from the lumen (Tah: Fig. 15 illustrates that the retractor wires as labeled 1514 is connected to spring 1518 and spring wire 1516 which extend all the way to the proximal end of the catheter as shown in Fig. 9, [0100], [0109]).
In regard to claims 29-30, 34 and 35, Gelbart/Tah combination further discloses the self-expanding mesh assembly is oval and cylindrical in the deployment position (see Fig. 3A; the overall 2D shape is oval and 3D shape is cylindrical).
Response to Arguments
Applicant’s Remarks filed on November 10, 2025 is fully acknowledged.
With respect to the rejection of claims 1-4, 7, 14, 21, and 26-34 under 35 U.S.C. 103 as being unpatentable over Gelbart et al. (U.S. PGPub. No. 2016/0008062) and Mustapha (U.S. PGPub. No. 2021/0030524), the arguments are moot since a new ground of rejection in view of Tah et al. (U.S. PGPub. No. 2015/0119895) is made above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOSEPH STOKLOSA can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 11/26/2025