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 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.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, drawn to an apparatus, classified in A61B5/287.
II. Claims 14-20, drawn to a method of manufacture, classified in A61M25/0009.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of making. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed may be made using a method attaching the flexible circuit to a monolithic, integrated framework comprising the insulating layer, rather than encapsulating the framework with a separate insulating layer.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
During a telephone conversation with Scott Denion (Reg. No. 76,757) on 07/27/2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fuentes-Ortega et al., (US 20210015551; hereinafter Fuentes).
Regarding claim 1, Fuentes (Figure 6) discloses an end effector (one leaflet 400) having a length (element z shown in annotated Figure 6 below) extending along a longitudinal axis from a proximal end to a distal end, a width (element y shown in annotated Figure 6 below) extending along a horizontal axis perpendicular to the longitudinal axis, and a thickness (element x shown in annotated Figure 6 below) extending along a vertical axis perpendicular to the longitudinal axis and the horizontal axis (i.e. in the axis extending perpendicular to this page), the end effector (400) comprising: a flexible circuit (flex circuit) comprising a plurality of electrodes (250/260), ([0048], [0055]: flex circuit comprising the electrodes 250/260 on the flex circuit substrate material of each leaflet), the flexible circuit (flex circuit) disposed on an insulative material ([0055]: flex circuit substrate material, e.g., polyimide, polyether ether ketone, etc.) and each electrode of the plurality of electrodes (250/260) comprising a contact surface, the insulative material (flex circuit substrate material) being contiguous to the contact surface so that only the contact surfaces of at least a portion of the plurality of electrodes (250/260) are exposed to an ambient environment ([0043]); and a framework (framework formed of integral nitinol strips) at least partially encapsulated in the insulative material (flex circuit substrate material) and curved along the width in a direction along the vertical axis such that the end effector (400) comprises a curvature along its width from about the proximal end to about the distal end ([0054]-[0056], [0062], [0069]: as shown in Figure 2C and particularly paragraph [0056], the resilient material, i.e. nitinol, of each leaflet 210, which corresponds to each leaflet 400, is curved along the width in the vertical axis perpendicular to the longitudinal axis of the device, i.e. directions x and y from annotated Figure 6 below, in the bulbous configuration of Figure 2C).
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Annotated Figure 6 from the Fuentes reference
Regarding claim 2, Fuentes discloses the end effector of claim 1, wherein the end effector (400) comprises the curvature along its width from about the proximal end to about the distal end ([0054]-[0055], [0062], [0069]), but fails to disclose the curvature comprising a radius (R) of about 8 millimeters to about 15 millimeters. However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fuentes to include the curvature comprising a radius of about 8 millimeters to about 15 millimeters since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 3, Fuentes (Figure 6) further discloses the radius of the curvature being uniform throughout the length of the end effector ([0062]: spheroid configuration).
Regarding claim 4, Fuentes (Figure 6) further discloses the radius of the curvature increasing from the proximal end to the distal end ([0065]: tulip configuration).
Regarding claim 5, Fuentes discloses the end effector of claim 4, but fails to disclose the radius of the curvature at the proximal end being approximately 4 millimeters. However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fuentes to include the radius of the curvature at the proximal end being approximately 4 millimeters since the radius of curvature is simply a result-effective variable which determines the degree of curvature of the end effector and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)(B).
Regarding claim 6, Fuentes (Figure 6) further discloses the framework (framework formed of integral nitinol strips) comprising a shape-memory material (nitinol) configured to return to a predefined-shape having the curvature at an activation temperature ([0075], [0087]).
Regarding claim 7, Fuentes (Figure 6) further discloses the activation temperature being about 37 degrees Celsius ([0075], [0087]: human body temperature).
Regarding claim 8, Fuentes (Figure 6) further discloses the shape-memory material comprising nitinol ([0054]-[0055], [0062], [0069], [0075]).
Regarding claim 9, Fuentes (Figure 6) further discloses an outer surface of the insulative material (flex circuit substrate material) comprising a plurality of creases along the length of the end effector (400), ([0054]-[0055], [0062], [0069], [0075]: as shown in Figure 8B, when the end effector takes on the 3D configuration, there are creases at the proximal and distal ends of the insulative material).
Regarding claim 10, Fuentes (Figure 6) further discloses an outer surface of the insulative material (flex circuit substrate material) being slanted (curved) between adjacent spines (410) of the framework (framework formed of integral nitinol strips), ([0054]-[0055], [0062], [0069]).
Regarding claim 11, Fuentes (Figure 6) further discloses the insulative material (flex circuit substrate material) further defining a gap (430) between at least one surface of the flexible circuit (422) and an interior surface of the insulative material (flex circuit substrate material), ([0054]-[0055], [0062], [0069]).
Regarding claim 12, Fuentes (Figure 6) further discloses a lumen (430) formed within the insulative material (flex circuit substrate material), ([0054]-[0055], [0062], [0069]).
Regarding claim 13, Fuentes (Figure 6) further discloses the lumen (430) disposed adjacent to spines (410) of the framework (framework formed of integral nitinol strips), ([0054]-[0055], [0062], [0069]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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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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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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