DETAILED ACTION
Response to Arguments
Applicant's arguments filed 3/30/26 have been fully considered but they are not persuasive.
Regarding Ahmed, Applicant asserts Ahmed does not meet the claim limitations, because Ahmed shows a separate insulative coating 131 on each of the conductors, in addition to the tube-forming polyimide layers 130 and 134. Examiner agrees with Applicant’s finding in Ahmed. However, after further review, the claims do not appear to exclude the presence of an additional insulative coating such as 131 in Ahmed, since the term “embed” does not necessarily require that the conductors are in direct contact with the recited outer insulating layer. Additionally, Ahmed also discloses the insulative coating 131 may be polyimide (Paragraph 64), the same material as the polyimide layers 130 and 134, which means that at least a top polyimide layer 134 would be directly deposited onto and thus integral with the top side of a polyimide insulative coating 131. Ahmed also discloses that alternatively, the five wires may be supplied on a flex circuit, which would be insulated on only one side. Examiner suggests possibly amending to recite the top and bottom surfaces of the conductors are in direct contact with the recited outer insulating layer, or similar phrasing. However, note that McMorrow (US 2010/0114278) shows deposited conductive traces embedded in an outer insulating layer.
The previous long/short axis note is kept for clarity of record.
Claim Interpretation
Examiner notes that long and short axes of an elongate shape may have multiple interpretations. For example, given a rectangle, the long and short axes of a rectangle may refer to the major and minor axes of symmetry, shown on the left below. However, the longest distance between vertices of a rectangle is actually the diagonal, shown on the right below.
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Other shapes may potentially raise other interpretations (e.g. how to consider axes of asymmetric shapes). For purposes of examination, the claim language is simply considered broad rather than indefinite, and considering Applicant’s disclosure and the prior art (e.g. Wessman), Examiner has applied the interpretation on the left above. Applicant may wish to consider reciting major and minor axes of symmetry. There may also be other mathematical terms applicable to this situation.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-15, 19-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ahmed (US 2006/0074318) in view of Wessman (US 7,039,470) and Schrom (US 2005/0027339).
Regarding claims 1, 4-14, Ahmed discloses substantially the same invention as claimed, including an intravascular device (abstract; Paragraph 3) comprising a guidewire extending in a longitudinal direction between a proximal portion and a distal portion, wherein the guidewire comprises a metallic inner core (Paragraph 13) and an outer insulating layer surrounding and directly contacting the metallic inner core (Paragraph 64), wherein the metallic inner core is configured to facilitate handling for the guidewire inside a vessel (Paragraphs 13, 54, 64), a plurality of conductors embedded in the outer insulating layer (Paragraph 64), wherein a conductor of the plurality of conductors comprises a top surface and an opposite, bottom surface, wherein at least the bottom surfaces of the plurality of conductors are embedded in the outer insulating layer (Figures 9, 9A-B; e.g. semi-circular top surface and semi-circular bottom surface; Paragraph 64), wherein the outer insulating layer comprises a plurality of openings exposing portions the top surfaces of the plurality of conductors (Figure 10; Paragraph 66), a connector disposed at the proximal portion of the guidewire and comprising a plurality of conductive sections positioned over the exposed portions of the top surfaces (Figures 10-11; Paragraph 67), and a sensor coupled to the distal portion of the guidewire and electrically coupled to the connector via the plurality of conductors (Paragraph 68).
Further regarding claim 1, Ahmed does not disclose the openings comprise an elongate shape with a long axis and short axis as recited. However, Wessman teaches using elongate-shaped openings comprising a long axis and short axis perpendicular to the long axis with exposed conductors (Figure 3), in order to create a more secure bond with the outer contact. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Ahmed as taught by Wessman to include an elongate opening as recited, in order to create a more secure bond with the outer contact.
Further regarding claims 1, 3, Ahmed or Wessman do not disclose the elongate opening having a long axis oriented only in the longitudinal direction as recited. However, Schrom teaches it is merely a matter of obvious engineering design choice to embed conductors either helically or straight along a lead body (Figures 12-13; Paragraphs 48, 51, 64, 69, 74, 77, 78) to suit the desired handling characteristics. Therefore, it would have been obvious to one with ordinary skill in the art at the time the invention was made to modify Ahmed and Wessman as taught by Schrom to include straight conductors as recited, since the choice between helical and straight conductors is merely a matter of obvious engineering design choice. In such an instance, the elongate openings of Ahmed and Wessman as modified by Schrom would then have a long axis oriented only in the longitudinal direction as recited.
Regarding claim 2, Ahmed discloses the thickness of the core is greater than the thickness of the outer insulating layer (Figure 9a; Paragraph 64).
Regarding claim 15, Ahmed discloses wherein the plurality of openings is located on a radially outward side of the plurality of conductors (Figure 10) and the outer insulating layer directly contacts the metallic inner core on an opposite, radially inward side of the plurality of conductors (Paragraph 64), wherein the plurality of conductive sections is located on the radially outward side (Figure 11; Paragraph 67).
Regarding claim 19, Ahmed discloses the outer insulating layer is positioned between the bottom surface of the conductor and the metallic inner core (Paragraph 64: an insulating layer directly contacts the metallic core and is thus between the conductor and inner core as recited).
Regarding claims 8, 20, Ahmed does not disclose a flat ribbon conductor as recited. However, Schrom teaches the embedded conductor shape is merely a matter of obvious engineering design choice (Paragraph 50: includes ribbon conductors). Therefore, it would have been obvious to one with ordinary skill in the art at the time the invention was made to modify Ahmed as taught by Schrom to include flat ribbon conductors as recited, since the shape of conductors is merely a matter of obvious engineering design choice. Examiner notes a ribbon conductor is understood in the art to have a non-circular cross-sectional shape with a top surface and an opposite, bottom surface. In the combination of Ahmed and Schrom, the exposed portions of the conductor would be considered the “top” surface.
Regarding claim 21, Ahmed discloses wherein a conductive section of the plurality of conductive sections comprises a first end segment, and opposite, second end segment, and a middle segment between the first and second end segments (Figure 11: each conductive contact can be considered to have first, second, and middle segments as recited) and positioned over an exposed portion of the top surface of the conductor (Figures 10-11; Paragraph 67; middle segment of conductive contact would be the part that is over the hole, top surface is the part of conductor that is exposed), wherein the first and second segments are positioned over an outer surface of the outer insulating layer adjacent to an opening of the plurality of openings such that the outer insulating layer is positioned between the top surface of the conductor and the first and second end segments (Figures 10-11; hole appears smaller than dimensions of conductive contact, thus the insulating layer would be sandwiched between as recited).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nee (US 2010/0318019), and Champeau (US 6,208,881) show similar structural designs.
THIS ACTION IS MADE FINAL. 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 Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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/Eugene T Wu/Primary Examiner, Art Unit 3792
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