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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 18 November 2025. As directed by the amendment: Claims 1 and 8 have been amended, Claims 6, 7, and 9-20 have been cancelled, and Claims 21-31 have been added. Thus, Claims 1-5, 8, and 21-31 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 8, and 21-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the claim recites “a frame extrusion disposed between the respective spine and a respective electrically insulative jacket comprising a proximal lumen and a distal lumen”. However, the claim also recites, “an electrically insulative jacket disposed between a respective spine of the plurality of spines and a respective electrode of the plurality of electrodes”. The claim does not explicitly state that the “an electrically insulative jacket” comprises a plurality of electrically insulative jackets, therefore it is unclear at what is intended by “a respective electrically insulative jacket”. Furthermore, it is unclear as to whether “a frame extrusion” is intended to also imply a plurality of frame extrusions, particularly due to the newly added dependent Claims 21-31. For purposes of examination, the Examiner is interpreting this limitation to recite “a plurality of frame extrusions” and “a plurality of electrically insulative jackets”. Appropriate correction or clarification is required. Claims 2-5, 8, and 21-31 are rejected for depending on Claim 1.
Regarding Claim 1, the claim recites, “the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen”. It is unclear as to how this structurally is intended to “fit the respective spine tighter”, since this appears to be an independent action in an apparatus claim (‘a medical probe’) and does not appear to result in a structural limitation as claimed. Therefore, this claim is indefinite. For purposes of examination, the Examiner is interpreting this limitation to recite “the frame extrusion tapers about the respective spine such that the distal lumen is smaller than the proximal lumen, and therefore fits the respective spine tighter than the proximal lumen”. Appropriate correction or clarification is required. Claims 2-5, 8, and 21-31 are rejected for depending on Claim 1.
Regarding Claims 25 and 26, the claims recite “the plurality of layers comprises: at least one full-length extrusion; a distal segment extrusion; and a proximal segment extrusion” and “the at least one full-length extrusion comprises a plurality of layers”. Firstly, it is unclear as to whether “a plurality of layers” in Claims 25 and 26 are referring to the same or different layers. Furthermore, these limitations are unclear as to the structure of the layers that is being claimed, since it is unclear as to whether these layers are located proximally/distally or centrally/peripherally (i.e., layers located next to one another, or layers stacked on top of one another). Therefore, the limitations in these claims are indefinite. For purposes of examination, the Examiner is interpreting these limitations as “the plurality of layers comprises proximal, distal, and central segments: at least one full-length extrusion; a distal segment extrusion; and a proximal segment extrusion” and “the at least one full-length extrusion comprises a plurality of additional layers”. Appropriate correction or clarification is required.
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 (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.
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 1, 3, 4, 5, 8, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Webster (US Patent No. 5,411,025, previously cited) in view of Selkee et al. (US Publication No. 2020/0345262).
Regarding Claims 1 and 8, Webster discloses a medical probe (Abstract; Col. 3, Lines 32-47), comprising: a tubular shaft (8, 6, 7, see Fig. 1 reproduced below) having a proximal end and a distal end, the tubular shaft extending along a longitudinal axis of the medical probe (Col. 2, Lines 30-55); and
an expandable basket assembly (“the arms flex outwardly to form a “basket”, the electrode forming a three-dimensional array”, Col. 2, Lines 42-45; See Fig. 1) coupled to the distal end of the tubular shaft (8, 6, 7, Fig. 1), the basket assembly comprising:
a plurality of spines (arms 9 comprising spine 25, Figs. 1, 2, 4) extending along the longitudinal axis and converging at a central spine intersection (distal central intersection 24, 25, 29, 14, Figs. 1, 6; Col. 6, Lines 37; see also proximal central intersection of spines in Fig. 5), each spine of the plurality of spines comprising:
a plurality of electrodes (11, see Fig. 2 reproduced below), each electrode comprising an electrode body (body 11, Fig. 2) that defines a lumen therethrough such that the respective spine (arms 9 comprising spine 25, Figs. 1, 2, 4) extends through the lumen (electrode 11 wraps around spine 25/arm 9, therefore spine 25/arm 9 extends through the lumen formed in electrode 11, Figs. 1-2; Col. 4, Lines 41-50; Col. 4, Lines 20-27), and
an electrically insulative jacket (18, Fig. 4; Col. 4, Lines 15-30; Col. 4, Lines 42-49; Col. 5, Lines 33-40) disposed between a respective spine (25, Fig. 4) of the plurality of spines and a respective electrode (electrode 11 wraps around spine 25 and insulation 18, Figs. 2, 4) of the plurality of electrodes, thereby electrically isolating the plurality of electrodes (11, Figs. 1-6) from the plurality of spines (arms 9 comprising spine 25, Figs. 1, 2, 4),
in which a cross-sectional shape of each electrode body (11, Fig. 1-2) and electrically insulative jacket (18, Fig. 4) comprises a substantially circular shape (circular shape of electrodes/insulation, see Figs. 1-4).
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Webster further discloses wherein each spine of the plurality of spines further comprises frame clamp elements (26, 27, 29, 30, Figs. 5-6) to secure the plurality of spines in the basket assembly (Col. 5, Line 58 – Col. 6, Line 26). However, Webster does not explicitly disclose a frame extrusion disposed between the respective spine and a respective electrically insulative jacket comprising a proximal lumen and a distal lumen, the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen, wherein the frame extrusion maintains a position of the electrically insulative jacked over the respective spine.
Selkee et al. teaches a medical probe comprising a tubular shaft (Abstract; 12, 14, Fig. 1) and a basket assembly (100, Fig. 1) at the distal end of the shaft (Paragraph 0027-0028) comprising a plurality of spines (1A-B, 2A-B, 3A-B, Fig. 1; Paragraph 0027-0028), a frame extrusion (see Fig. 5D annotated below) disposed between respective spine and a respective electrically insulative jacket (spine 1C, 2C, 3C and nonconductive covering 64, see Fig. 5D annotated below, Paragraph 0042, 0048) comprising a proximal lumen and a distal lumen (lumens through which spines are located, see Fig. 5D annotated below; Paragraph 0042, 0048), the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen (see Fig. 5D annotated below; Paragraph 0042, 0048), wherein the frame extrusion maintains a position of the electrically insulative jacket over the respective spine (see Fig. 5D annotated below; Paragraph 0042, 0048).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a frame extrusion disposed between the respective spine and a respective electrically insulative jacket comprising a proximal lumen and a distal lumen, the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen, as taught by Selkee et al., in the medical probe disclosed by Webster, in order to maintain a position of the electrically insulative jacket/nonconductive covering and “to seal the distal end and provide an atraumatic dome” (Paragraph 0048 of Selkee et al.).
Regarding Claim 3, Webster discloses a medical probe further wherein the electrically insulative jacket (insulative tubing 18, Fig. 4; Col. 4, Lines 15-30; Col. 4, Lines 42-49; Col. 5, Lines 33-40) is disposed along at least a portion of the respective spine (insulation tubing 18 extends along arms 9 comprising spine 25, Figs. 1, 2, 4).
Regarding Claim 4, Webster discloses a medical probe further wherein the electrically insulative jacket (insulative tubing 18, Fig. 4; Col. 4, Lines 15-30; Col. 4, Lines 42-49; Col. 5, Lines 33-40) is disposed along an entire length of the respective spine except for the central spine intersection (“the metal portion of each spine 25 extends beyond the plastic tubing 18 at each end and attaches to the two fittings 12 and 14”, Col. 5, Lines 57-60, see Figs. 1-6, insulative tubing 18 does not extend through proximal and distal central intersections, see Figs. 5 and 6).
Regarding Claim 5, Webster discloses a medical probe further wherein the electrically insulative jacket (insulative tubing 18, Fig. 4; Col. 4, Lines 15-30; Col. 4, Lines 42-49; Col. 5, Lines 33-40) is disposed along an entire length of the respective spine except for the respective spine ends (“the metal portion of each spine 25 extends beyond the plastic tubing 18 at each end and attaches to the two fittings 12 and 14”, Col. 5, Lines 57-60, see Figs. 1-6, insulative tubing 18 does not extend through proximal and distal central intersections, see Figs. 5 and 6).
Regarding Claim 21, Webster discloses a medical probe further wherein the plurality of spines comprise a substantially semi-circular/flat cross-sectional shape (cross section of 25, Fig. 4; Col. 5, Lines 18-57), and wherein the electrically insulative jacket (18, Fig. 4; Col. 4, Lines 15-30; Col. 4, Lines 42-49; Col. 5, Lines 33-40) comprises a body defining an opening therethrough such that the respective spine (25, Fig. 4; Col. 5, Lines 18-57) extends through the electrically insulative jacket body, wherein the opening comprises a substantially circular or semi-circular cross-sectional shape (circular cross section of tubing 18, Fig. 4; Col. 5, Lines 18-57; semi-circular cross section of additional insulation of 25, see Fig. 4; Col. 5, Lines 33-40). However, Webster does not explicitly disclose a frame extrusion comprising a proximal lumen and a distal lumen, the proximal lumen has a substantially circular cross-sectional shape and the distal lumen has a substantially rectangular cross-sectional shape, the frame extrusion does not extend over a center of the respective spine.
Selkee et al. teaches a medical probe comprising a tubular shaft (Abstract; 12, 14, Fig. 1) and a basket assembly (100, Fig. 1) at the distal end of the shaft (Paragraph 0027-0028) comprising a plurality of spines (1A-B, 2A-B, 3A-B, Fig. 1; Paragraph 0027-0028), a frame extrusion comprising a proximal lumen and a distal lumen (lumens through which spines are located, see Fig. 5D annotated below; Paragraph 0042, 0048), the frame extrusion does not extend over a center of the respective spine (frame extrusion does not extend the length of spine or to center, see Fig. 5D annotated below), with different cross sectional chapes of the lumens including circular/rectangular (see Fig. 5D annotated below; Paragraph 0011, 0042-0043, 0048; Claim 6).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a frame extrusion comprising a proximal lumen and a distal lumen, with different cross sectional chapes of the lumens including circular/rectangular, and the frame extrusion does not extend over a center of the respective spine, as taught by Selkee et al., in the medical probe disclosed by Webster, in order to maintain a position of the electrically insulative jacket/nonconductive covering and “to seal the distal end and provide an atraumatic dome” (Paragraph 0048 of Selkee et al.).
However, Selkee et al. does not explicitly disclose the proximal lumen has a substantially circular cross-sectional shape and the distal lumen has a substantially rectangular cross-sectional shape. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the proximal lumen to have a substantially circular cross-sectional shape and the distal lumen to have a substantially rectangular cross-sectional shape, in the medical probe taught by Webster and Selkee et al., since such a modification would have involved a mere change in the form or shape of a component (the spine/leg and the insulative jacket). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claims 22 and 23, Webster discloses a medical probe wherein each spine of the plurality of spines further comprises frame clamp elements (26, 27, 29, 30, Figs. 5-6) to secure the plurality of spines in the basket assembly (Col. 5, Line 58 – Col. 6, Line 26). However, Webster does not explicitly disclose the frame extrusion is disposed along an entire length of the respective spine except for the central spine intersection and the distal spine end, and wherein the frame extrusion comprises a distal frame extrusion proximate the central spine intersection and a proximal frame extrusion proximate the spine end.
Selkee et al. teaches a medical probe comprising a tubular shaft (Abstract; 12, 14, Fig. 1) and a basket assembly (100, Fig. 1) at the distal end of the shaft (Paragraph 0027-0028) comprising a plurality of spines (1A-B, 2A-B, 3A-B, Fig. 1; Paragraph 0027-0028), a frame extrusion (see Fig. 5D annotated above) disposed between respective spine and a respective electrically insulative jacket (spine 1C, 2C, 3C and nonconductive covering 64, see Fig. 5D annotated above, Paragraph 0042, 0048), the frame extrusion is disposed along an entire length of the respective spine except for the central spine intersection and the distal spine end (see Fig. 5D annotated above, Paragraph 0042, 0048), and wherein the frame extrusion comprises a distal frame extrusion proximate the central spine intersection and a proximal frame extrusion proximate the spine end (see Fig. 5D annotated above, Paragraph 0042, 0048). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a frame extrusion disposed along an entire length of the respective spine except for the central spine intersection and the distal spine end, and wherein the frame extrusion comprises a distal frame extrusion proximate the central spine intersection and a proximal frame extrusion proximate the spine end, as taught by Selkee et al., in the medical probe disclosed by Webster, in order to maintain a position of the electrically insulative jacket/nonconductive covering and “to seal the distal end and provide an atraumatic dome” (Paragraph 0048 of Selkee et al.).
Furthermore, although Selkee et al. teaches distal frame extrusions at the distal end of the spine as described in detail above, neither Webster nor Selkee et al. discloses an additional proximal frame extrusion proximate the spine end. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include an additional proximal frame extrusion proximate the spine end, for the purpose of maintain a position of the electrically insulative jacket/nonconductive covering and “to seal the distal end and provide an atraumatic dome” (Paragraph 0048 of Selkee et al.) on the proximate spine end, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding Claims 24 and 25, Webster discloses a medical probe wherein each spine of the plurality of spines further comprises frame clamp elements (26, 27, 29, 30, Figs. 5-6) to secure the plurality of spines in the basket assembly (Col. 5, Line 58 – Col. 6, Line 26). However, Webster does not explicitly disclose a frame extrusion comprising a plurality of layers, the plurality of layers comprises: at least one full-length extrusion; a distal segment extrusion; and a proximal segment extrusion. It is noted that “layers” in this context is indefinite, see 35 U.S.C. 112(b) rejections above, and thus will be interpreted as “segments” as claimed.
Selkee et al. teaches a medical probe comprising a tubular shaft (Abstract; 12, 14, Fig. 1) and a basket assembly (100, Fig. 1) at the distal end of the shaft (Paragraph 0027-0028) comprising a plurality of spines (1A-B, 2A-B, 3A-B, Fig. 1; Paragraph 0027-0028), a frame extrusion (see Fig. 5D annotated above) disposed between respective spine and a respective electrically insulative jacket (spine 1C, 2C, 3C and nonconductive covering 64, see Fig. 5D annotated above, Paragraph 0042, 0048), wherein the frame extrusion comprises a plurality of layers, the plurality of layers comprises: at least one full-length extrusion; a distal segment extrusion; and a proximal segment extrusion (see annotated Fig. 5D below).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a frame extrusion comprising a plurality of layers, the plurality of layers comprises: at least one full-length extrusion; a distal segment extrusion; and a proximal segment extrusion, as taught by Selkee et al., in the medical probe disclosed by Webster, in order to maintain a position of the electrically insulative jacket/nonconductive covering and “to seal the distal end and provide an atraumatic dome” (Paragraph 0048 of Selkee et al.).
Claims 2 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Webster (US Patent No. 5,411,025, previously cited) in view of Selkee et al (US Publication No. 2020/0345262), further in view Danek et al. (US Patent No. 7,425,212, previously cited).
Regarding Claim 2, Webster discloses a medical probe further wherein the plurality of spines comprise a substantially semi-circular/flat cross-sectional shape (cross section of 25, Fig. 4; Col. 5, Lines 18-57), and wherein the electrically insulative jacket (18, Fig. 4; Col. 4, Lines 15-30; Col. 4, Lines 42-49; Col. 5, Lines 33-40) comprises a body defining an opening therethrough such that the respective spine (25, Fig. 4; Col. 5, Lines 18-57) extends through the electrically insulative jacket body, wherein the opening comprises a substantially circular or semi-circular cross-sectional shape (circular cross section of tubing 18, Fig. 4; Col. 5, Lines 18-57; semi-circular cross section of additional insulation of 25, see Fig. 4; Col. 5, Lines 33-40).
However, Webster does not explicitly disclose wherein the spines and the opening in the insulative body both comprise a substantially rectangular cross-sectional shape. Danek et al. teaches a medical probe (Abstract; Col. 12, Lines 12-22; Col. 3, Lines 32-65) including an expandable basket assembly (302, 304, Figs. 5A-B), the basket assembly comprising a plurality of spines (106, Figs. 5A-5B, 5J-5L) including a plurality of electrodes (energy transfer elements, Col. 12, Lines 12-22; Col. 16, Lines 6-32) and electrically insulative body (134, Fig. 5K and other insulative coatings/heat shrink; Col. 13, Lines 19-35; Col. 16, Lines 10-20; Col. 18, Lines 35-42), wherein the spines and the opening in the insulative body both comprise a substantially rectangular cross-sectional shape (coated/insulated rectangular/flat ribbon shaped spine legs 106, Figs. 5A-5B, 5J-5L; Col. 12, Lines 41-56; Col. 3, Lines 32-50; Col. 18, Lines 7-45).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure both the spines and the opening in the body to be a substantially rectangular cross-sectional shape, as taught by Danek et al., in the medical probe disclosed by Webster, since Webster additionally teaches that a flat edge of a cross-section of the spine “provide[s] greater lateral stability, yet have sufficient flexibility for opening into the "basket" shape when the inner catheter 6 is extended out of and collapsed into outer catheter tube 8” (Col. 5, Lines 41-47, Webster) and “allows the arms 9 of the basket to be retracted into and extended from the outer catheter tube 8 and otherwise subjected to bending, such as from the beating heart chamber, yet still return to its proper shape, even if extremely deformed” (Col. 5, Lines 22-33, Webster). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure both the spines and the opening in the body to be a substantially rectangular cross-sectional shape, as taught by Danek et al., in the medical probe disclosed by Webster, since such a modification would have involved a mere change in the form or shape of a component (the spine/leg and the insulative jacket). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claims 27-30, Webster discloses a medical probe wherein each spine of the plurality of spines further comprises frame clamp elements (26, 27, 29, 30, Figs. 5-6) to secure the plurality of spines in the basket assembly (Col. 5, Line 58 – Col. 6, Line 26). However, Webster does not explicitly disclose a frame extrusion comprising a plurality of layers, the plurality of layers comprises: at least one full-length extrusion; a distal segment extrusion; and a proximal segment extrusion. It is noted that “layers” in this context is indefinite, see 35 U.S.C. 112(b) rejections above, and thus will be interpreted as “segments” as claimed.
Selkee et al. teaches a medical probe comprising a tubular shaft (Abstract; 12, 14, Fig. 1) and a basket assembly (100, Fig. 1) at the distal end of the shaft (Paragraph 0027-0028) comprising a plurality of spines (1A-B, 2A-B, 3A-B, Fig. 1; Paragraph 0027-0028), a frame extrusion (see Fig. 5D annotated above) disposed between respective spine and a respective electrically insulative jacket (spine 1C, 2C, 3C and nonconductive covering 64, see Fig. 5D annotated above, Paragraph 0042, 0048), wherein the a frame extrusion comprises layers that are electrically insulating (non-conductive, Paragraph 0046-0048) and may comprise polyurethane or PEBAX (Paragraph 0046-0048).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a frame extrusion disposed between the respective spine and a respective electrically insulative jacket comprising a proximal lumen and a distal lumen, the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen, as taught by Selkee et al., in the medical probe disclosed by Webster, in order to maintain a position of the electrically insulative jacket/nonconductive covering and “to seal the distal end and provide an atraumatic dome” (Paragraph 0048 of Selkee et al.).
However, Selkee et al. does not explicitly disclose that the frame extrusion comprises a coating including a heat shrink material and/or comprises one or more of silicone, urethane, parylene, polyether block amide, or polyethylene terephthalate. Danek et al. teaches a medical probe (Abstract; Col. 12, Lines 12-22; Col. 3, Lines 32-65) including an expandable basket assembly (302, 304, Figs. 5A-B), the basket assembly comprising a plurality of spines (106, Figs. 5A-5B, 5J-5L) including a plurality of electrodes (energy transfer elements, Col. 12, Lines 12-22; Col. 16, Lines 6-32) and electrically insulative coating on a frame extrusion including a heat shrink material and/or comprises polyethylene terephthalate [PET] (134, Fig. 5K and other insulative coatings/heat shrink such as PET; Col. 13, Lines 19-35; Col. 16, Lines 10-30; Col. 18, Lines 35-42),.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the frame extrusion to include a coating including a heat shrink material and/or polyethylene terephthalate [PET] as taught by Danek et al., in the medical probe disclosed by Webster and Selkee et al. in combination, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding Claim 31, Webster discloses a medical probe wherein each spine of the plurality of spines further comprises frame clamp elements (26, 27, 29, 30, Figs. 5-6) to secure the plurality of spines in the basket assembly (Col. 5, Line 58 – Col. 6, Line 26), and Selkee et al. teaches a medical probe comprising a tubular shaft (Abstract; 12, 14, Fig. 1) and a basket assembly (100, Fig. 1) at the distal end of the shaft (Paragraph 0027-0028) comprising a plurality of spines (1A-B, 2A-B, 3A-B, Fig. 1; Paragraph 0027-0028), a frame extrusion (see Fig. 5D annotated above) disposed between respective spine and a respective electrically insulative jacket (spine 1C, 2C, 3C and nonconductive covering 64, see Fig. 5D annotated above, Paragraph 0042, 0048). However, neither Webster nor Selkee et al. discloses wherein the frame extrusion comprises a notch internal the distal lumen to engage with a respective spine.
Danek et al. teaches a medical probe (Abstract; Col. 12, Lines 12-22; Col. 3, Lines 32-65) including an expandable basket assembly (302, 304, Figs. 5A-B), the basket assembly comprising a plurality of spines (106, Figs. 5A-5B, 5J-5L) including a plurality of electrodes (energy transfer elements, Col. 12, Lines 12-22; Col. 16, Lines 6- 32) and electrically insulative body (134, Fig. 5K and other insulative coatings/heat shrink; Col. 13, Lines 19-35; Col. 16, Lines 10-20; Col. 18, Lines 35-42), a frame extrusion (notches 148, Fig. 8C; Col. 18, Lines 30-45) comprising an internal notch (148, Fig. 8C) deposed between a respective spine (106, Figs. 5A-5B, 8C) and a respective notch in the electrically insulative jacket (134, Fig. 5K), wherein the frame extrusion (notches 148, Fig. 8C; Col. 18, Lines 30-45) and maintains a position of the electrically insulative jacket (134, Fig. 5K) over the respective spine (respective/corresponding notches 148 in spine and insulative jacket, since "In this variation, the leg 106 has a region of increased diameter 148 in the case of round wire, or increased width or thickness in the case of rectangular or other non-axisymmetric wire. Such a region 106 could also be a flat wire with bumps or protrusions creating areas of increased width of the flat wire. This region 148 may, for example, provide a stop that assists in locating insulation, heat shrink, or other external covering around the leg 106.", Col. 18, Lines 32-43).
Therefore, it would have been obvious to one having ordinary skill in the art
before the effective filing date of the claimed invention to include a frame extrusion
comprising a notch internal the distal lumen to engage with a respective spine, as
taught by Danek et al., in the medical probe disclosed by Webster and Selkee et al. in combination, in order to maintain a position of the electrically insulative jacket and "provide a stop that assists in locating insulation, heat shrink, or other external covering around the leg", as also taught by Danek et al. (Col. 18, Lines 32-43), since such a modification would have involved a mere change in the form or shape of a component (the basket spine/legs). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Webster (US Patent No. 5,411,025, previously cited) in view of Selkee et al. (US Publication No. 2020/0345262), further in view of Willard (US Publication No. 2015/0018818).
Regarding Claim 26, Webster discloses a medical probe wherein each spine of the plurality of spines further comprises frame clamp elements (26, 27, 29, 30, Figs. 5-6) to secure the plurality of spines in the basket assembly (Col. 5, Line 58 – Col. 6, Line 26), and Selkee et al. teaches a medical probe comprising a tubular shaft (Abstract; 12, 14, Fig. 1) and a basket assembly (100, Fig. 1) at the distal end of the shaft (Paragraph 0027-0028) comprising a plurality of spines (1A-B, 2A-B, 3A-B, Fig. 1; Paragraph 0027-0028), a frame extrusion (see Fig. 5D annotated above) disposed between respective spine and a respective electrically insulative jacket (spine 1C, 2C, 3C and nonconductive covering 64, see Fig. 5D annotated above, Paragraph 0042, 0048), wherein the frame extrusion comprises a plurality of layers, the plurality of layers comprises: at least one full-length extrusion; a distal segment extrusion; and a proximal segment extrusion (see annotated Fig. 5D above) as described in detail above.
However, neither Webster nor Selkee et al. discloses wherein the at least one full-length extrusion comprises a plurality of layers.
Willard teaches a medical probe (Abstract) comprising a plurality of spines that form a basket (Paragraph 0007, 0031), and at least one full-length extrusion of the spines (114, 116, 135, Figs. 2A-B) comprises a plurality of layers (base layers 125a, 125b, and additional insulating layers comprising silicone or PTFE, Paragraph 0036, 0040, 0042-0044; see Fig. 2B). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the frame extrusion in the medical probe as disclosed by Webster and Selkee et al. in combination to have at least one full-length extrusion comprises a plurality of layers, as taught by Willard, in order to secure the spine elements and to effectively provide insulation, since it has been held that mere duplication of the essential working parts of a device (i.e. multiple layers) involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Response to Arguments
The Applicant's arguments filed 18 November 2025 with respect to the previous 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 rejections of Claims 1-5 and 8 have been fully considered.
The Applicant specifically argues (Pages 5-7 of Amendment/Response filed 18 November 2025) that the previously cited Webster references does not disclose all of the claimed elements of Claim 1 as amended, specifically wherein the medical probe includes “a frame extrusion disposed between the respective spine and a respective electrically insulative jacket comprising a proximal lumen and a distal lumen, the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen”. However, the newly cited Selkee et al. reference teaches these limitations, in a new 35 U.S.C. 103 rejection made above.
Although Webster further discloses wherein each spine of the plurality of spines further comprises frame clamp elements (26, 27, 29, 30, Figs. 5-6) to secure the plurality of spines in the basket assembly (Col. 5, Line 58 – Col. 6, Line 26), the Examiner agrees that Webster does not explicitly disclose a frame extrusion disposed between the respective spine and a respective electrically insulative jacket comprising a proximal lumen and a distal lumen, the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen.
Selkee et al. teaches a medical probe comprising a tubular shaft (Abstract; 12, 14, Fig. 1) and a basket assembly (100, Fig. 1) at the distal end of the shaft (Paragraph 0027-0028) comprising a plurality of spines (1A-B, 2A-B, 3A-B, Fig. 1; Paragraph 0027-0028), a frame extrusion (see Fig. 5D annotated below) disposed between respective spine and a respective electrically insulative jacket (spine 1C, 2C, 3C and nonconductive covering 64, see Fig. 5D annotated below, Paragraph 0042, 0048) comprising a proximal lumen and a distal lumen (lumens through which spines are located, see Fig. 5D annotated below; Paragraph 0042, 0048), the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen (see Fig. 5D annotated below; Paragraph 0042, 0048).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a frame extrusion disposed between the respective spine and a respective electrically insulative jacket comprising a proximal lumen and a distal lumen, the frame extrusion tapers about the respective spine such that the distal lumen fits the respective spine tighter than the proximal lumen, as taught by Selkee et al., in the medical probe disclosed by Webster, in order to maintain a position of the electrically insulative jacket/nonconductive covering and “to seal the distal end and provide an atraumatic dome” (Paragraph 0048 of Selkee et al.).
With respect to dependent Claim 2, the Applicant further argues (Pages 7-9 of Amendment/Response) that neither of previously cited Webster nor Danek et al. explicitly teaches or suggests all of the claimed elements of Claim 2, particularly “wherein the plurality of spines comprise a substantially rectangular cross-sectional shape; and wherein the electrically insulative jacket comprises a body defining an opening therethrough such that the respective spine extends through the electrically insulative jacket body, wherein the opening comprises a substantially rectangular cross-sectional shape”. However, the Examiner disagrees with these arguments. Firstly, in response to the Applicant's arguments against the Webster and Danek et al. references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As described above, Webster discloses a medical probe further wherein the plurality of spines comprise a substantially semi-circular/flat cross-sectional shape (cross section of 25, Fig. 4; Col. 5, Lines 18-57), and wherein the electrically insulative jacket (18, Fig. 4; Col. 4, Lines 15-30; Col. 4, Lines 42-49; Col. 5, Lines 33-40) comprises a body defining an opening therethrough such that the respective spine (25, Fig. 4; Col. 5, Lines 18-57) extends through the electrically insulative jacket body, wherein the opening comprises a substantially circular or semi-circular cross-sectional shape (circular cross section of tubing 18, Fig. 4; Col. 5, Lines 18-57; semi-circular cross section of additional insulation of 25, see Fig. 4; Col. 5, Lines 33-40).
However, the Examiner agrees that Webster does not explicitly disclose wherein the spines and the opening in the insulative body both comprise a substantially rectangular cross-sectional shape. Danek et al. teaches a medical probe (Abstract; Col. 12, Lines 12-22; Col. 3, Lines 32-65) including an expandable basket assembly (302, 304, Figs. 5A-B), the basket assembly comprising a plurality of spines (106, Figs. 5A-5B, 5J-5L) including a plurality of electrodes (energy transfer elements, Col. 12, Lines 12-22; Col. 16, Lines 6-32) and electrically insulative body (134, Fig. 5K and other insulative coatings/heat shrink; Col. 13, Lines 19-35; Col. 16, Lines 10-20; Col. 18, Lines 35-42), wherein the spines and the opening in the insulative body both comprise a substantially rectangular cross-sectional shape (coated/insulated rectangular/flat ribbon shaped spine legs 106, Figs. 5A-5B, 5J-5L; Col. 12, Lines 41-56; Col. 3, Lines 32-50; Col. 18, Lines 7-45).
Therefore, the Examiner maintains that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure both the spines and the opening in the body to be a substantially rectangular cross-sectional shape, as taught by Danek et al., in the medical probe disclosed by Webster, since Webster additionally teaches that a flat edge of a cross-section of the spine “provide[s] greater lateral stability, yet have sufficient flexibility for opening into the "basket" shape when the inner catheter 6 is extended out of and collapsed into outer catheter tube 8” (Col. 5, Lines 41-47, Webster) and “allows the arms 9 of the basket to be retracted into and extended from the outer catheter tube 8 and otherwise subjected to bending, such as from the beating heart chamber, yet still return to its proper shape, even if extremely deformed” (Col. 5, Lines 22-33, Webster). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure both the spines and the opening in the body to be a substantially rectangular cross-sectional shape, as taught by Danek et al., in the medical probe disclosed by Webster, since such a modification would have involved a mere change in the form or shape of a component (the spine/leg and the insulative jacket). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
No additional specific arguments were made with respect to the previous rejections of dependent Claims 3-5 and 8, nor with respect to new Claims 21-31. Therefore, Claims 1-5, 8, and 21-31 are rejected as described in detail 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.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796