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 .
The current application has the priority date to 12/30/2022,
Claim Status
Applicant’s election without traverse of Group I: claims 1-11 in the reply filed on 02/05/2026 is acknowledged.
Claims 12-20 are withdrawn from examination.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“elongate digit” in claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Interpretation
To claim 2, the limitation “a location sensing coil layer” is not defined by a ‘location-sensing’ feature as drafted, thus this term imparts no particular structure or functional feature. At least in claim 2 (or unless otherwise explicitly disclosed), “location sensing coil layer” is treated as a structure “comprising a plurality of coils disposed generally parallel to the framework and separated from the framework by a third non-conductive flexible layer”
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 9-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Spector US 2023/0190166 A1.
Regarding claim 1, Spector discloses a multilayered end effector (electrode array 103) for a catheter (cardiac mapping catheter 100, exemplary as shown in Figs. 1-4, also see [0031]), the end effector (103) comprising:
a first flexible circuit ([0038] “each of the tines or splines may comprise a first side and a second side opposite the first side such that electrodes of the electrode array are positioned apart on the tines. The electrodes may be on the first side, i.e. the top side of the tine or spline and/or on the second side, i.e. the bottom side of the tine or spline” and [0039] “Each of the two flat sides of the tines may contain a plurality of electrodes such that each electrode 113 may be positioned as groups of adjacent electrodes forming an array. Thus, the tines or splines may comprise a flexible printed circuit (FPC)” In here, a first or top side of the spline or tine comprising electrodes and thus, the FPC is taken to encompass “a first flexible circuit” in this claim) extending along a longitudinal axis from a proximal portion to a distal portion of the end effector (the plurality of tines 105 or splines extending from the catheter shaft through the electrode array as shown in Figs.1-4), the first flexible circuit comprising a first face and a second face ([0038-0039] first/top face as shown in Fig. 1, this is also the face exposed to the exterior, the second face is interior or the side facing the framework- not shown);
a framework (flexible support frame 115 disposed along the tines 105 as shown in Figs. 1-3, also see [0032, 0037]) comprising a first side and an opposite second side (Figs. 1-3: 115, first/top side is shown in Fig. 1, and an opposite second side is not shown), and extending along the longitudinal axis generally parallel to the first flexible circuit and with the first side spaced apart from the first flexible circuit (see Figs. 1-4, frame 115 is spaced apart from the tines 105);
a first non-conductive flexible layer (deformable surface 107) at least partially encapsulating the first flexible circuit and the framework ([0035-0037] deformable surface 107 is a flexible membrane where the tines 105, electrode 113 and support frame 115 are retained within; as shown in Fig. 1-4 the first/top side as shown in taken to encompass “a first non-conductive flexible layer” in the claim);
a second flexible circuit ([0038] “each of the tines or splines may comprise a first side and a second side opposite the first side such that electrodes of the electrode array are positioned apart on the tines. The electrodes may be on the first side, i.e. the top side of the tine or spline and/or on the second side, i.e. the bottom side of the tine or spline” and [0039] “Each of the two flat sides of the tines may contain a plurality of electrodes such that each electrode 113 may be positioned as groups of adjacent electrodes forming an array. Thus, the tines or splines may comprise a flexible printed circuit (FPC)” In here, second or bottom side of the spline or tine comprising electrodes and thus, the FPC is taken to encompass “a first flexible circuit” in this claim) disposed on the second side of the framework and spaced apart from the framework, the second flexible circuit having a first face and a second face ([0038-0039] first face of the “second flexible circuit” is the second or bottom side of tines with electrodes, this is also the side exposed to the exterior; second face is interior to the electrode array 103); and
a second non-conductive flexible layer (deformable surface 107) at least partially encapsulating the second flexible circuit and the framework ([0035-0037] deformable surface 107 is a flexible membrane where the tines 105, electrode 113 and support frame 115 are retained within; the second opposite/bottom not shown in Figs.1-4 is taken to encompass “a second non-conductive flexible layer” in the claim).
Regarding claim 2, Spector teaches the end effector of claim 1, further comprising: a location sensing coil layer comprising a plurality of coils (magnetic coils 123) disposed generally parallel to the framework and separated from the framework by a third non-conductive flexible layer (as shown in Fig. 7, magnetic sensing coil 123 is separate from the frames 115 and encapsulated by the deformable surface 107; see [0046]).
Regarding claim 3, Spector teaches the end effector according to claim 2, further comprising: one or more first electrodes (113) affixed to the first face of the first flexible circuit ([0038] “each of the tines or splines may comprise a first side and a second side opposite the first side such that electrodes of the electrode array are positioned apart on the tines. The electrodes may be on the first side, i.e. the top side of the tine or spline and/or on the second side, i.e. the bottom side of the tine or spline.” Electrodes on the first/top side interpreted to encompass “first electrodes affixed to the first face of the first flexible circuit” in this claim), each of the one or more first electrodes having a contact surface exposed through the first non-conductive flexible layer to the ambient environment ([0038, 0057] electrodes on the first side, are exposed via opening 207, the electrodes 113 are disposed along a copper trace 201 and copper pad which are part of the tine’s 105 FCO as shown in Fig. 2).
Regarding claim 4, Spector teaches the end effector according to claim 3, further comprising one or more second electrodes (113) affixed to a first face of the second flexible circuit ([0038] “each of the tines or splines may comprise a first side and a second side opposite the first side such that electrodes of the electrode array are positioned apart on the tines. The electrodes may be on the first side, i.e. the top side of the tine or spline and/or on the second side, i.e. the bottom side of the tine or spline.” Electrodes on the second/bottom side interpreted to encompass “second electrodes affixed to the first face of the second flexible circuit” in this claim), each of the one or more second electrodes having a contact surface exposed through the second non-conductive flexible layer to the ambient environment ([0038, 0057] electrodes on the second side, i.e. the bottom side of the tine or spline 105 are exposed via opening 207, the electrodes 113 are disposed along a copper trace 201 and copper pad which are part of the tine’s 105 FCP as shown in Fig. 2). [AltContent: rect]
Regarding claim 5, Spector teaches the end effector according to claim 4, in which at least a portion of the first electrodes (113) are axially aligned, orthogonal to the longitudinal axis, with at least a position of the second electrodes (113) to define pairs of opposite facing electrodes. ([0049] “The electrode pair is generally arranged in an orthogonal, close, unipolar (OCU) configuration. More specifically, the common axis between the first and second electrodes (referred to as the “inter-electrode axis”) is “orthogonal” to a given surface at the target site when a recording is performed”; also see [0038, 0048-0050])
Regarding claim 9, Spector teaches the end effector of claim 1, further comprising one or more first electrodes disposed in the first non-conductive flexible layer and having a contact surface exposed through the first non-conductive flexible layer to the ambient environment. ([0038, 0057] electrodes on the first face/side of the tine or spline 105 are exposed via opening 207, the electrodes 113 are disposed along a copper trace 201 and copper pad which are part of the tine’s 105 FCP as shown in Fig. 2)
Regarding claim 10, Spector teaches the end effector of claim 9, further comprising one or more second electrodes disposed in the second non-conductive flexible layer, each of the one or more second electrodes having a contact surface exposed through the second non-conductive flexible layer to the ambient environment. (([0038, 0057] electrodes on the second side, i.e. the bottom side of the tine or spline 105 are exposed via opening 207, the electrodes 113 are disposed along a copper trace 201 and copper pad which are part of the tine’s 105 FCP as shown in Fig. 2). [AltContent: rect]
Regarding claim 11, Spector teaches the end effector according to claim 1, in which the end effector (103) remains in contact against a generally planar surface with a force applied to the proximal portion of the end effector in a vertical axis with respect to the generally planar surface. (The array 103 defines a planar surface which is configured to remain in contact with a generally planar surface tissue; [0017] “Exemplary methods include providing an electrode array comprising a flexible support frame such that, upon deployment from a sheath, the electrode array conforms to the shape of a tissue and lies substantially flat when deployed against the tissue.”)
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.
Claim 8 is under 35 U.S.C. 103 as being unpatentable over Spector as applied to claim 1 above.
Spector: annotated Fig. 3 below
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Regarding claim 8, Spector discloses the end effector according to claim 1, further comprising a plurality of pairs of first electrodes disposed on the first face of the first flexible circuit, the electrodes of each pair of first electrodes being spaced apart a first predetermined longitudinal distance (Fig.2 illustrating a first and second electrode along one edge of a tine , this is interpreted as “one/each pair” in this claim, see [0048, 0051] inter-electrode distance between each pair is a known distance) and each pair of first electrodes spaced apart from adjacent pairs of first electrodes a second predetermined longitudinal distance (see Figs. 1-4, a plurality of pairs of stacked pairs of electrodes along each tine 105). Spector discloses that all electrodes along each longitudinal axis has the same ‘known distance’ in [0051]. Spector does not disclose the second predetermined longitudinal distance being greater than the first predetermined longitudinal distance. However, this would have been an obvious design choice at the time of invention to separate electrode pairs by different known distance; the motivation for doing so is for visual recognition, and/or for electrical isolation of neighboring electrode pairs.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Spector as applied to claim 1 above, and in view of Reniers US 2016/0282461.
Regarding claim 6, Spector teaches the end effector according to claim 2, the plurality of coils comprising two coils (coils 123, [0046]), but Spector does not teach wherein the two coils are joined together at a union lying generally along the longitudinal axis, and the location sensing coil layer further comprising: a central spine extending distally from the proximal portion to the union.
Renier, another prior art reference in the analogous art discloses a system for wirelessly locating objects or determining a position of a tube or catheter using an antenna array of two partially overlapping coils as shown in Fig. 2. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Spector so as to modify the coils to join together in view of Renier, as it provides the advantage of a large dynamic range for multiple f.sub.0 to achieve enough measurement distance to detect the electromagnetic reflector inside a human body of different sizes with a minimum amount of RF (electromagnetic) power benefits. (Reiner [0005])
Regarding claim 7, Spector modified discloses the end effector according to claim 6, the location sensing coil layer further comprising at least one elongate digit extending from the plurality of coils. (see Spector Figs. 1 and 3: coil 123 is illustrated as “an elongate digit”)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
March 4, 2026