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 statements (IDS) submitted on 10/4/2023, 11/26/2024, 5/19/2025 were 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 statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, Species A, in the reply filed on 12/30/2025 is acknowledged.
Claims 6 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and/or Species B, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
In the instant application, no claim limitations are being interpreted as invoking 112(f).
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, 2, 4, 5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murayama et al (US 2004/0030266 A1) as evidenced by Chen et al (examiner supplied NPL, “On the factor affecting the critical indenter penetration for measurement of coating hardness”) and Xu et al (examiner supplied NPL, “Method for Determining Film Hardness and Thickness by Indentation”).
Regarding claims 1, 2, 4, 5 and 7; Murayama discloses a guide wire (figures 6 and 7) comprising:
a first shaft (element 2), and
a second shaft (element 3) including a distal end (element 21) joined (at joint element 14) to a proximal end (element 31) of the first shaft, the second shaft being formed of a material exhibiting an elastic modulus higher than an elastic modulus of a material forming the first shaft (“The first wire 2 and the second wire 3 may be made from different alloys, and particularly, the first wire 2 is preferably made from a material having an elastic modulus smaller than that of the material of the second wire 3”, paragraph [0068]; “Since the second wire 3 is made from a material having an elastic modulus larger than that of the first wire 2 […]“, paragraph [0081]), wherein:
the second shaft includes a variable hardness portion (element 32, figures 5 and 6) comprising:
a first portion (element 32b) having a hardness that gradually decreases from a distal end of the first portion to a proximal end of the first portion (wherein the examiner notes that the measured composite hardness of a material obtained by a Vickers hardness test on element 32b will decrease as the thickness of step filler coating element 6 increases since the step filler element is made of soft material which less hard than wire material of element 3; paragraph [0088] and [0091]-[0103] and see also further explanation below as detailed by evidentiary references; figures 6-7), and
a second portion (element 32c) arranged proximally of the first portion, the second portion exhibiting a hardness lower than the hardness of the distal end of the first portion (wherein the thickness of soft step filling element 6 is greater in sections 32a and 32c than at distal end of 32b, thus resulting in a lower hardness; paragraphs [0088] and [0091]-[0103] and see also further explanation below as detailed by evidentiary references; figures 6-7); ,
a length of the variable hardness portion in an axial direction (length of element 32) of the guide wire is longer than a diameter (diameter of element 3) of the second shaft (wherein paragraphs [0084] discloses the length of element 32 in the range of 3-300 mm which is greater than the diameter of the guidewire disclosed in the range of 0.2-1.2 mm as disclosed in paragraph [0051]).
Although Murayama is silent to the hardness of the variable diameter region (element 32) of the second shaft (wire element 2), Murayama does disclose the portion (element 32) of the second shaft (element 3) which has a region with a decreasing diameter taper towards the proximal end (element 32b) and another region (element 32c) having a diameter which is less than the decreasing tapering region (paragraphs [0096]-[0103]; figures 6 and 7). Murayama also discloses that the stepped portion is filled in with a soft material such as solder, plastic or wax (paragraphs [0086]-[0088] and [0103]), all of which have a lower hardness than the harder materials described for the second wire (paragraph [0061]-[0068]). Both evidentiary reference to Chen and Xu provide the teaching and knowledge that in situations where a soft material is coated on a harder substrate, that the thickness of the material affects the measured hardness of the composite material as the testing of the hardness measured at the thinner coated area is affect by the hardness of the substrate it is placed upon, and as the thickness increases the measured hardness approaches that of the lower hardness coating material (“In hardness measurement, when the film thickness is extremely low, the substrate inevitably participates in the deformation process during indentation, undergoing partial plastic deformation. This results in the measured hardness value reflecting not the true film hardness, but rather the composite hardness of the film–substrate system”, Xu introduction paragraph 2, figures 2 and 3; and “Initially, the main effect from the substrate is to impose constraint on the deformation in the coating because it is much stiffer and harder. It was observed that the relative hardness significantly increases when the RID [relative indentation depth) > 0.3. Fig. 4 shows the plastic deformation zone for this type of coating when the RID = 0.35, where no plastic deformation occurs in the substrate”, Chen 2nd paragraph of p. 914). Therefore, based on the disclosed structure of Murayama and the evidence as described in Chen and Xu, the resultant hardness of Murayama’s variable diameter section (element 32) filled with a soft step filling material (element 6) would also result in a variable hardness region which is dependent on the thickness of the filler, wherein portions where the filling material is thinner would result in a higher hardness than portions where the filling material has a greater thickness because the hardness of the wire under the step filling material would contribute the measured hardness of the guidewire in that axial portion. As such, Murayama’s embodiment disclosed in figures 6 and 7 meets the limitations of the instantly claimed invention’s variable hardness portion as outlined and described above.
Further regarding claim 2; Murayama disclose the second shaft includes a distal end portion (element 32b) including the distal end of the second shaft, and the variable hardness portion is arranged proximally of the distal end portion (wherein section 32b is proximal of distal end element 21; figure 6).
Further regarding claim 4; Murayama discloses the variable hardness portion has a low hardness part (element 32c) exhibiting a hardness lower than a hardness of the distal end portion of the second shaft (whereas described and explained above, the hardness at the distal end of 32b would be higher than the hardness as 32c because the filling material is thinner, and thus the hardness of the substrate would more greatly affect the measured hardness of the guidewire at that location than a location where the filling material element 6 is thicker; see figure 6).
Further regarding claim 5; Murayama discloses a length of the low hardness part in the axial direction is longer than the diameter of the second shaft (wherein Murayama discloses the length of 32C in the range of 1-50 mm in paragraph [0102] which anticipates being greater than the disclosed range of 0.2-1.2 mm diameter of the guidewire in paragraph [0052] with sufficient specificity as the large majority of the disclosed range of the length of 32C is greater than the small amount of overlapping of ranges with the guidewire diameter, see MPEP 2131.03, II).
Further regarding claim 7; Murayama discloses the second shaft includes a hardness increasing part (element 32a of embodiment figure 6) arranged proximally of the variable hardness portion, the hardness increasing part having a hardness that gradually increases from a distal end of the hardness increasing part to a proximal end of the hardness increasing part (wherein as described and explained above, the measured hardness of the guidewire in 32A would increase the more proximal it is measured as the hardness of the substrate would contribute more to the hardness measurement as the filling material thickness decreases).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Murayama as evidenced by Xu and Chen.
Murayama is described in the rejections of claims 1 and 2 above; however Murayama does not explicitly disclose that the distal end portion of the second shaft exhibits a hardness lower than the distal end of the variable hardness portion. However, Murayama does discloses that purpose of variable diameter portion (element 32 of figures 5 and 6) is to prevent and relieve stress concentration at the boundary portion (element 14) of the first shaft (element 2) and the second shaft (element 3) to prevent torsion or kinking (i.e. improve kick resistance). It further discloses that elastic modulus of the second shaft (element 3) is greater than the elastic modulus of the first shaft (element 2) (paragraphs [0068] and [0081]). Elastic modulus and hardness are positively correlated and thus exhibits that the hardness of the second shafter is greater than the hardness of the first shaft. As Murayama discloses that the goal of the variable diameter/hardness portion is to prevent and relieve stress concentration at the boundary portion between the first and second shaft, it would have been obvious to one of ordinary skill in the art at the time of filing to have the hardness of the distal end portion of the second shaft (where the diameter of shaft 2 is equal to that of the diameter of shaft 3) be lower than the hardness of the distal end of the variable thickness portion (element 32) to be closer to than of the lower elastic modulus distal first shaft (element 2) in order to further provide a gradual transition from the second shaft to the first shaft to prevent and relieve stress concentration at the boundary portion (element 14) of the first shaft (element 2) and the second shaft (element 3) to prevent torsion or kinking (i.e. improve kick resistance).
Examiner’s Note: The examiner invites the applicant to set up an interview with the examiner to discuss possible amendments to hep differentiate from the prior art of record in the hope of advancing the application to allowance.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2023/0302260 A1 to Marayama; discloses a guide wire and method of manufacturing guide wire.
US 2014/0200555 A1 to Simpson et al; discloses method for counteracting rebounding effects during solid state resistance welding of dissimilar materials.
US 6,488,637 to Eder et al; discloses a composite endovascular guidewire.
US 2008/0234606 A1 to Itou; discloses a guide wire.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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