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.
No limitations of the instant claims are interpreted as invoking an 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, 8, 9, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abner (US 2015/0148706 A1).
Regarding claims 1-4, 8, 9, 11 and 15; Abner discloses an intravascular device (guidewire, element 10), comprising:
a core (element 12) having a proximal section (element 26) and a distal section (combined elements 24, 22, 20 and 18; figure 1);
a first tube (element 16) having a proximal section and a distal section, wherein the first tube (element 16) is coupled to the core (element 12) such that the distal section of the core passes into and is encompassed by the first tube (wherein core, elements 24, 22, 20 and 18 extend into first tube, element 16; figure 1); and
a second tube (element 14) having substantially the same outer diameter as the first tube (wherein examiner notes that figure 1 depicts second tube, element 14, and first tube, element 16, as having substantially the same outer diameter), wherein the second tube (element 14) is coupled to the core (element 12) such that the proximal section (element 26) of the core passes into and is encompassed by the second tube (element 14) (wherein all of core proximal section, element 26, passes into and is encompassed by second tube, element 14; figure 1),
wherein the second tube (element 14) extends over at least 50% of the length of the proximal section of the core (wherein examiner notes that the entirety of core proximal section, element 26, is within second tube, element 14; figure 1).
Further regarding claims 2 and 3; Abner discloses the second tube (element 14) extends over at least 75% of the length of the proximal section of the core (wherein examiner notes that the entirety of core proximal section, element 26, is within second tube, element 14; figure 1).
Further regarding claim 3; Abner discloses the second tube extends over substantially the complete length of the proximal section of the core (wherein examiner notes that the entirety of core proximal section, element 26, is within second tube, element 14; figure 1).
Further regarding claim 4; Abner discloses at least a portion of the proximal section of the first tube (element 16) passes into and is encompassed by the second tube (element 14) (wherein examiner notes that proximal end of first tube, element 16, tapers into the distal end of second tube, element 14; figure 1).
Further regarding claims 8 and 9; Abner discloses the second tube has a variable inner diameter (wherein the inner diameter of the second tube, element 14, gets larger in the transition area where the second tube, element 14, meets the first tube, element 16; figure 1).
Further regarding claim 9; Abner discloses the variable inner diameter is larger at a proximal section of the second tube and smaller at a distal section of the second tube (wherein the inner diameter of second tube, element 14, gets larger as it extends distally until the guidewire transitions to the first tube, element 16; figure 1).
Further regarding claim 11; Abner discloses the second tube (element 14) extends farther proximally than the core (element 26) such that a proximal end of the core terminates at a distal section of the second tube (wherein second tube, element 14, extends proximal to the proximal end of the core, element 26, and as such the core, element 12, terminates at a distal section of the second tube [where it is noted that any section more distal than the proximal most section of element 14 meets the BRI of a distal section of the second tube]; figure 1)).
Further regarding claim 15; Abner discloses the first tube and the second tube contact each other at a joint (transition between second tube, element 14, and first tube, element 16), and wherein a proximal end of the core (element 26) is disposed 0.5 cm to 5 cm proximal of the joint (wherein the examiner notes that Abner discloses the length of section D2 may be 2-10 cm or about 5 cm, and the joint between the second tube, element 14, and first tube, element 16, occurs in section D2, therefore the joint would be located within 2-10 or 5 cm of proximal end of core, element 26, as it discloses an overlapping range which meets .5 cm to 5 cm with sufficient specificity; paragraph [0027]; figure 1).
Claim Rejections - 35 USC § 102/103
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)(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 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 6, 7 and 10 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Abner (cited above).
Regarding claims 6 and 10; Abner is described in the rejection of claim 1 above. Furthermore, Abner discloses a list of materials that the various components of the guidewire can be made of which include polymers and metals (paragraphs [0040]-[0041]). Therefore, Abner discloses and contemplates embodiments where the second tube comprises a polymer (claim 6) or where the second tube is formed from metal (claim 10).
In the alternative, as Abner discloses a genus of possible materials that various components of the guidewire can be made of ( “The materials that can be used for the various components of guidewire 10 may include metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials”; paragraph [0040]); however, Abner does not explicitly list the species: where the second tube comprises a polymer (claim 6) or where the second tube is formed from metal (claim 10). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the second tube out of a polymer (claim 6) or form the second tube of metal (claim 10) as obvious to try, choosing from a finite number of identified predictable solutions to yield a predictable result (in this case, the second tube could be formed of any materials provided in the list of materials, including a polymer or metal; paragraphs [0040]-[0041]).
Regarding claim 7; the examiner notes this is a product-by-process claim (wherein laminating the second tube to the proximal section of the core is a process); and that as such, the patentability is based on the product itself, and does not depend on its method of production. It has been established that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. See MPEP 2113.
In this case, the examiner contends that Abner anticipates claim 7 as it discloses an equivalent product as Abner discloses the second tube (element 14, which may be a polymer, paragraph [0040]) is disposed on the proximal section (element 26) of the core (element 12) (see figure 1); which is the equivalent product to the second tube is laminated to the proximal section of the core.
In the alternative, Abner discloses the second tube (element 14) is disposed on the on the proximal section (element 26) of the core (element 12) (see figure 1), but does not explicitly disclose the method of attachment of the second tube. The examiner takes official notice that it would have been obvious to one of ordinary skill in the art at the time of filing to put the second tube on the proximal section using known methods of applying polymers, including through well-known and conventional processes such as lamination.
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 5, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Abner (cited above).
Regarding claim 5, 17 and 18; Abner discloses an intravascular device (guidewire, element 10), comprising:
a core (element 12) having a proximal section (element 26) and a distal section (combined elements 24, 22, 20 and 18; figure 1);
a first tube (element 16) having a proximal section and a distal section, wherein the first tube (element 16) is coupled to the core (element 12) such that the distal section of the core passes into and is encompassed by the first tube (wherein core, elements 24, 22, 20 and 18 extend into first tube, element 16; figure 1); and
a second tube (element 14) having substantially the same outer diameter as the first tube (wherein examiner notes that figure 1 depicts second tube, element 14, and first tube, element 16, as having substantially the same outer diameter), wherein the second tube (element 14) is coupled to the core (element 12) such that the proximal section (element 26) of the core passes into and is encompassed by the second tube (element 14) without any space between an outer surface of the proximal section of the core and an inner surface of the second tube (wherein all of the core proximal section, element 26, passes into and is encompassed by second tube, element 14, and no gap is depicted as it is directly applied to the core, element 12; figure 1),
wherein the second tube (element 14) extends over at least 50% of the length of the proximal section of the core (wherein examiner notes that the entirety of core proximal section, element 26, is within second tube, element 14; figure 1);
wherein the second tube has a variable inner diameter (wherein the inner diameter of the second tube, element 14, gets larger in the transition area where the second tube, element 14, meets the first tube, element 16; figure 1); and
wherein at least a portion of the proximal section of the first tube (element 16) passes into and is encompassed by the second tube (element 14) (wherein examiner notes that proximal end of first tube, element 16, tapers into the distal end of second tube, element 14; figure 1).
However, Abner does not explicitly disclose wherein the second tube has a lower elastic modulus than the first tube.
Abner does disclose “other structural modifications may also be utilized to define an inflection point such as stiffened regions of core wire 12, structures secured to core wire 12 to impart stiffness, changes in the location and/or composition of the sections of core wire 12, changes in the composition and/or location of sheath 14 and/or tip member 16, or the like.” (paragraph [0038]). As such, Abner contemplates changes in composition/stiffness of both the sheath and/or tip member in order to provide certain functions.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Abner’s guidewire such that the second tube has a lower elastic modulus than the first tube as obvious to try, selecting from a finite number of identified predictable solutions (in this case, either the second tube [element 14] elastic modules is greater than, equal too, or less than the elastic modulus of the first tube [element 16]) to yield a predictable result (a guidewire wherein the second tube has a lower elastic modulus than the first tube in order to provide a desired shape/function).
Further regarding claim 18; Abner discloses the second tube (element 14) extends over substantially the complete length of the proximal section (element 26) of the core (element 12) (figure 1).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Abner as applied to claims 1 and 15 above, and further in view of Iwami et al (US 7,278,973).
Regarding claim 16; Abner is described in the rejection of claims 1 and 15 above; however, Abner is silent to an adhesive disposed at the joint between the first tube and second tube.
Iwami teaches a guidewire having first and second tubes (element 31 and 32, respectively) over a core wire (element 2) wherein the first tube and second tube meet at a joint and the first tube is joined to the second tube by adhesive bonding (column 15, lines 37-45; figure 4).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Abner such that the an adhesive is disposed at the joint between the first tube and the second tube as taught by Iwami in order to securely join the tubes together at the joint.
Claims 12, 13, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Abner as applied to claims 1 and 11 above, and further in view of Lippert et al (US 2019/0290883).
Abner is described in the rejections of claims 1 and 11 above; but does not explicitly disclose wherein a portion of a lumen of the second tube containers a polymer filler (claims 12 and 19), wherein the filler has an elastic modulus of 1 MPa to 1000 MPa (claims 13 and 20), or wherein the filler comprises a metal (claims 14 and 19).
Lippert discloses a hybridized guidewire having a proximal hypotube section (element 14) wherein the hypotube can be machined to cut away portions to provide a desired flexibility/stiffness (paragraph [0102]), wherein the machined portions of the outer tube lumen are filled with a polymer filler to maintain structural integrity and fill the gaps such that even if a beam/ring of the cut tube breaks it remains as one piece within the patient’s vasculature to ease removal (paragraphs [0115] and [0118]).
Regarding claims 12, 13, 19 and 20; Abner discloses a second tube and that the second tube can be altered in order to provide a desired structural stiffness (paragraph [0038]). Lippert teaches an alternative method to alter the flexibility/stiffness of a proximal metal tube. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the stiffness/flexibility of the second tube made of metal by machining as taught by Lippert in order to provide the desired stiffness to that section of the guidewire. Furthermore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Abner/Lippert combination to include a polymer filler in at least a portion of the lumen defined by the outer diameter of the second tube made by the machining cuts with a polymer filler as taught by Lippert in order to fill the gaps and provide structural integrity such that even if a beam/ring of the cut tube breaks it would remain as one piece within the patient’s vasculature to ease removal.
Further regarding claims 13 and 20; Lippert discloses the polymer filler material can be made of PEBA which has a modulus of approximately 10 to 500 MPa which is within the claimed range of 1 MPa to 1000 MPa. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Abner/Lippert combination to use PEBA as the polymer filler as taught by Lippert as the filler material provides the integrity but does not affect the overall guidewire flexibility (paragraph [0119]).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Abner in view of Lippert as applied to claim 12 above, and further in view of Japanese Patent Document JP 2009-515656 A (herein referred to as “Japan”; examiner notes that citations are from included English Machine Translation).
The Abner/Lippert combination is described in the rejection of claims 1 and 12 above; however, it does not explicitly disclose the filler comprises a metal.
Japan teaches that metal fibers can be used as micro and/or nano sized fillers in a polymers in order to impart desired strength, flexibility or other characteristics to a shaft which is inserted into the body (4th and 5th paragraphs of page 5 of provided English translation: “By careful selection of materials and processing techniques, thermoplastic, solvent soluble and thermosetting variants of these materials can be used to achieve the desired results. In some cases, thermoplastic polymers such as copolyester thermoplastic elastomers, such as those sold as ARNITEL (R) can be used. In some cases, the thermoplastic polymer can include micro-sized fillers, and even nano-sized fillers. Examples of suitable fillers include metal fibers, ceramic fibers, nanoclays, and carbon structures such as carbon fibers and carbon tubes.”).
Regarding claim 14; the Abner/Lippert combination teaches providing a polymer filling to the second tube as described in the rejection of claim 12 above. Japan teaches providing a polymer with metal micro/nano-sized fillers in order to impart desired strength, flexibility or other desirable characteristics to the polymer layer of a shaft which is inserted into the body. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Abner/Lippert combination such that the polymer filler further comprises metal micro/nano-fibers as taught by Japan in order to impart desirable characteristics to the second tube section of the Abner/Lippert combination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2008/0312597 A1 to Uihlein; discloses a guidewire for a medical instrument.
US 2004/0167439 A1 to Sharrow; discloses a gudiewrie having a texture proximal portion.
US 5,876,356 to Viera et al; discloses a super elastic guidewire with a shapeable tip.
US 5,836,893 to Urick; discloses an intravascular guidewire.
US 6,142,975 to Jalisi et al; discloses a guidewire having a braided wire over drawn tube construction.
US 5,111,829 to Alvarez de Teledo; discloses a steerable highly elongated guidewire.
US 11,426,560 B2 to Telang; discloses a guidewire made from a drawn filled tube of stainless steel sheath and nitinol core.
US 5,385,152 to Abele et al; discloses a guidewire for crossing occlusions in blood vessels.
US 5,749,837 to Palermo et al; discloses an enhanced lubricity guidewire.
US 5,452,726 to Burmeister et al; discloses a intravascular guidewire and method of manufacture thereof.
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