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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/11/2025 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Currently, no claims appear to invoke a 35 USC 112(f) interpretation.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4, 6-9, 13-15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voeller et al (US 2009/0036834 A1).
Regarding claims 1-4, 6-9, 13-15; Voeller discloses an intravascular device (figures 1 and 2), comprising:
a core (element 28) having a proximal section (section of core, element 28, proximal to first diameter reduction; see annotated figure below) and a distal section (section of core, element 28, distal to second diameter reduction; see annotated figure below), wherein the core includes a stepped shoulder (constant diameter section between first diameter reduction and second diameter reduction) at a transition from the proximal section to the distal section (located between proximal section and distal section), the stepped shoulder having a constant outer diameter (constant diameter), the core forming a distally facing surface proximal of the stepped shoulder (surface of core element 28 at diameter transitions from proximal section to shoulder section; see annotated figure below); and
a tube (element 30) coupled to the core (via element 32 and/or 36) at the stepped shoulder (wherein examiner notes that Voeller discloses a step-wise transition structure for core element 28 instead of tapered, see paragraph [0044], and in a step-wise diameter transitions [i.e. not tapered, such that the diameter transition zones would be a single dotted line in the annotated figure below], the at least one of the connection points 32 and 36 is located at the stepped shoulder), the distal section of the core passing into and being encompassed by the tube (see annotated figures 1 and 2 below).
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Further regarding claim 2; Voeller discloses the outer diameter of the stepped shoulder and an inner diameter of the tube are substantially similar (see annotated figures 1 and 2 above; wherein the examiner notes that the is a very small gap between the outer diameter of core element 28 and inner diameter of tube element 30, thus making them substantially similar [absent any specific definition of substantially from the specification]).
Further regarding claim 3; Voeller discloses an outer diameter of the tube is substantially the same as an outer diameter of the proximal section of the core (see annotated figures 1 and 2 above; wherein the examiner notes that the outer diameter of proximal section of core element 28 and outer diameter of tube element 30 are nearly identical, thus making them substantially similar [absent any specific definition of substantially from the specification]).
Further regarding claim 4; Voeller discloses an outer diameter of the tube is greater than an outer diameter of the proximal section of the core (see enlarged and annotated figure 2 below).
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Further regarding claim 6; Voeller discloses the tube is formed from a super-elastic material (discloses tube, element 30, can be made of super-elastic material; paragraph [0047]).
Further regarding claim 7; Voeller discloses at least a portion of the distal section of the core is a flat ribbon (discloses distal end of core, element 28, can be thin rectangular ribbon; paragraph [0044]).
Further regarding claim 8; Voeller discloses the core is formed from stainless steel (discloses core, element 28, can be made of stainless steel; paragraph [0047]).
Further regarding claim 9; Voeller discloses a radiopaque element disposed at or near a distal end of the device (discloses radiopaque material on device at distal end; paragraph [0040]).
Further regarding claim 13; Voeller discloses the distally facing surface is perpendicular to a longitudinal axis of the core (wherein Voeller discloses embodiment with step-wise reductions in diameter, then the surface formed by the step would be perpendicular to the longitudinal axis of the core; paragraph [0044]).
Further regarding claim 14; Voeller discloses the tube abuts the distally facing surface (see annotated figures 1 and 2 above; wherein tube element 30 abuts the surface of diameter reduction locations between proximal and shoulder section of core element 28).
Further regarding claim 15; Voeller discloses the distal section of the core further comprises one or more tapered shoulders distal of the stepped shoulder (Voeller disclose the core, element 28, may have smoothly tapering section, step-wise transitions, or both, and thus contemplates an embodiment having a tapered shoulder section distal to the stepped shoulder identified in the rejection of claim 1; paragraph [0044]; see annotated figures 1 and 2).
Further regarding claim 18; Voeller discloses an intravascular device (figures 1 and 2), comprising:
a core (element 28) having a proximal section (section of core, element 28, proximal to first diameter reduction; see annotated figures 1 and 2 above) and a distal section (section of core, element 28, distal to second diameter reduction; see annotated figures 1 and 2 above), wherein the core includes a stepped shoulder (constant diameter section between first diameter reduction and second diameter reduction) at a transition from the proximal section to the distal section (located between proximal section and distal section), the stepped shoulder having a constant outer diameter (constant diameter of section between proximal and distal sections), the core forming a distally facing surface proximal of the stepped shoulder (surface of core element 28 at diameter transition from proximal section to shoulder section; see annotated figure 1 and 2 above), wherein the distally facing surfacer is perpendicular to a longitudinal axis of the core (wherein Voeller discloses embodiments with step-wise reductions in diameter, thus the surface formed by the step-wise reduction is diameter would be perpendicular to the longitudinal axis of the core; paragraph [0044]; and
a tube (element 30) coupled to the core (via element 32 and/or 36) at the stepped shoulder (wherein examiner notes that Voeller discloses a step-wise transition structure for core element 28 instead of tapered, see paragraph [0044], and in a step-wise diameter transitions [i.e. not tapered, such that the diameter transition zones would be a single dotted line in the annotated figures 1 and 2 above], the at least one of the connection points 32 and 36 is located at the stepped shoulder), the distal section of the core passing into and being encompassed by the tube (see annotated figures 1 and 2 above), the tube abutting the distally facing surface (see annotated figures 1 and 2 above; wherein tube element 30 abuts the surface of diameter reduction locations between proximal and shoulder section of core element 28),
wherein the outer diameter of the stepped shoulder and an inner diameter of the tube are substantially similar (see annotated figures 1 and 2 above; wherein the examiner notes that the is a very small gap between the outer diameter of core element 28 and inner diameter of tube element 30, thus making them substantially similar [absent any specific definition of substantially from the specification]),
wherein an outer diameter of the tube is substantially the same as an outer diameter of the proximal section of the core (see annotated figures 1 and 2 above; wherein the examiner notes that the outer diameter of proximal section of core element 28 and outer diameter of tube element 30 are nearly identical, thus making them substantially similar [absent any specific definition of substantially from the specification]).
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.
The factual inquiries 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 10-12, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Voeller (as cited in the 35 USC 102 rejection above).
Regarding claims 10-11 and 19; Voeller is descried in the rejection of claims 1 and 18 above; however, Voeller does not explicitly disclose that the tube (element 30) in the embodiment used in the rejection of claims 1 and 18 includes a plurality of fenestrations (claims 10 and 19) wherein the plurality of fenestrations for a plurality of axially extending beamsand a plurality of circumferentially extending rings (claims 11 and 19).
In an alternate embodiment, Voeller discloses the tube (element 46) at the end of the guidewire (element 43) includes a plurality of fenestrations (element 48) wherein the plurality of fenestrations form a plurality of axially extending beams (longitudinally extending parts of the tube) and a plurality of circumferentially extending rings (ring elements of the tube) (paragraph [0043]; figure 10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the tube (element 30) at the distal end of the guidewire in figures 1 or 2 with the tube (element 46) at the distal end of the guidewire in figure 10 as simple substitution of one known element for another to yield a predictable result (in this case, a guidewire having the core of the guidewire of figures 1 and 2 with the tube (element 46) of the guidewire from figure 10).
Regarding claim 12; Voeller is described in the rejection of claim 1 above; but it does not explicitly disclose the stepped shoulder has a length of about 1 cm to about 20 cm as Voeller is silent to dimensions. Voeller does disclose the stepped shoulder has a length (by its existence in figure 1 and 2). It would have been obvious to one of ordinary skill in the art at the time of filing to modify Voeller’s guidewire to have a stepped shoulder that has a length of about 1 cm to about 20 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the guidewire of Voeller would not operate differently with the claimed length of the stepped shoulder portion being about 1 cm to about 20 cm and the guidewire would function appropriately having the claimed shoulder length. Further, it appears that the applicant places no criticality on the range claimed, simply indicating that the shoulder “can have” outer a length within the claimed range (see paragraphs [0012] and [0038] of the published specification of the instant application).
Regarding claims 17 and 20; Voeller is described in the rejection of claims 1 and 18 above; however, it does not explicitly disclose that the stepped shoulder has an outer diameter that is 30% to 90% of the outer diameter of the proximal section of the core.
Voeller does disclose a stepped shoulder which has a diameter smaller than the outer diameter of the proximal section of the core, but does not disclose any values for the outer diameter of the proximal section of the core or the diameter of the stepped shoulder portion (see figures 1 and 2). It would have been obvious to one of ordinary skill in the art at the time of filing to modify Voeller’s guidewire to have a stepped shoulder that has an outer diameter that is 30% to 90% of the outer diameter of the proximal section of the core since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the guidewire of Voeller would not operate differently with the claimed outer diameter of the stepped shoulder portion being 30% to 90% of the outer diameter of the proximal section of the core and the guidewire would function appropriately having the claimed diameter. Further, it appears that the applicant places no criticality on the range claimed, simply indicating that the diameter “can have” outer diameters within the claimed ranges (see paragraphs [0011] and [0045] of the published specification of the instant application).
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Voeller as applied to claim 1 above, and further in view of Davis et al (US 2020/0222672 A1).
Regarding claim 5, Voeller is described in the rejection of claim 1 above; furthermore, Voeller discloses the medical device may have a lubricous coating.
However, Voeller is silent that the lubricous coating is a hydrophilic coating.
Davis teaches a similar guidewire wherein the guidewire can have a hydrophilic coating and that hydrophilic coatings are suitable coatings for guidewires (paragraph [0066]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make Voeller’s lubricous coating be a hydrophilic coating as taught by Davis as it is a well known coating for providing a lubricous surface to move the guidewire through the body.
Regarding claim 16; Veoller is described in the rejection of claim 1 above; however, Voeller does not disclose the guidewire further comprises one or more coils disposed between the core and the tube.
Davis teaches a similar guidewire wherein there are one or more coils (elements 212 and 214) disposed between the core (element 203) and the tube (element 204) in order to center the core inside the tube (paragraphs [0034]-[0043]; figures 3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Voeller’s guidewire to further include one or more coils disposed between the core and the tube as taught by Davis in order to help center the core within the tube.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 8,360,995 B2 to Elsesser et al; discloses a wire guide having a shoulder and distal tube (see figures 1 and 3-5).
US 4,971,490 to Hawkins; discloses a flexible guidewire with improved mounting arrangement for a coil spring tip that includes a shoulder section and tube/coil (see figures 3 and 4).
US 5,682,894 to Orr et al; discloses a guide wire having a shoulder and distal tube/coil (see figures 1-4).
DE 4445879 A1 to Uihlein; discloses a guide wire having a shoulder and distal tube/coil (see figures 1 and 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/Primary Examiner, Art Unit 3791