Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/15/26 has been entered.
Notice of Amendment
In response to the amendment(s) filed on 1/27/26, amended claim(s) 1, 5, 7, 13, 21, and 23-24 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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 negatived by the manner in which the invention was made.
Claim(s) 1-11, 13, 21, and 26-28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2004/0167442 to Shireman et al. (hereinafter “Shireman”) in view of U.S. Patent No. 6,491,648 to Cornish et al. (hereinafter “Cornish”), U.S. Patent Application Publication No. 2002/0062092 to Muni et al. (hereinafter “Muni”), and U.S. Patent Application Publication No. 2008/0077049 to Hirshman.
For claim 1, Shireman discloses a method for fabricating (Abstract) a medical device (10) (Fig. 1) (para [0027]), the method comprising:
fabricating an elongate shaft member (12, 14, and 16 together) (Fig. 1) (para [0027]) that includes an elongate proximal portion (12 and 14) (Fig. 1) (para [0027]);
a distal portion (16) (Fig. 1) (para [0027]) extending distally from the elongate proximal portion (para [0027]), a first portion of the distal portion comprising a practitioner-shapeable distal end section (portion of 16 distal of 26 “proximal end 26 of distal portion 16,” (see para [0052]) that can include elements 33, 35, and 39) (Fig. 1) (also see para [0027]), wherein the practitioner-shapeable distal end section is formed of a nickel-titanium alloy member (para [0029]) comprising a first cross-sectional dimension (“cross-section,” para [0039]);
treating the practitioner-shapeable distal end section with a metal hydroxide (para [0082]);
applying a first layer of solder material (63) (Figs. 3-5) (para [0079] and [0082]) to the practitioner-shapeable distal end section (as can be seen in Figs. 3-5) without allowing the practitioner-shapeable distal end section to make contact with air (“pre-tinning,” para [0082]) (Examiner’s Note: Applicant’s specification also identifies the process of pre-tinning as achieving this claimed function of not allowing the section to make contact with air, see para [0012] and [0049] of Applicant’s specification as originally filed);
cold working the practitioner-shapeable distal end section (para [0029] discloses that element 16 may comprise nickel-titanium alloy in addition to solder to form the wire and para [0031] discloses that the wire may be cold worked “in such a way that it does not display a substantial ‘superelastic plateau’ or ‘flag region’ in its stress/strain curve”), wherein the cold working yields a distal practitioner-shapeable end section which exhibits linear elastic deformation behavior (“nickel-titanium alloy such as linear elastic or superelastic (i.e., pseudoelastic) nitinol,” para [0029]) (also see para [0030]-[0036]),
soldering (para [0076]-[0077]) the practitioner-shapeable distal end section and a helical coil section (80) (as can be seen in Figs. 1 and 8) (para [0084]) disposed around the practitioner-shapeable distal end section (as can be seen in Figs. 1 and 8) to an atraumatic cap (69) (Figs. 1 and 2) (para [0076]) (also see “atraumatic tip,” para [0116]), such that the practitioner-shapeable distal end section maintains the linear elastic deformation behavior (para [0031], the entire wire is fabricated such that (“…it does not display a substantial ‘superelastic plateau’ or ‘flag region’ in its stress/strain curve,”) (also see para [0094], which states that the coil may be made of pseudoelastic nitinol), wherein a portion of the helical coil section is embedded within the atraumatic cap (as can be seen in Figs. 1-2) and secured to the practitioner-shapeable distal end section at a proximal location and at an intermediate location (as can be seen in Figs. 1-2 and 8) (also see para [0089]); and
fabricating a second portion of the distal portion (26) (Figs. 1-2) (para [0027]) (also see para [0052], which discloses that 26 is a portion of 16) proximal to and between the practitioner-shapeable distal end section and a joint (12) (Figs. 1-2) (para [0027]) located at a terminal distal end of the elongate proximal portion (as can be seen in Figs. 1-2), wherein the second portion of the distal portion is formed of a superelastic nickel-titanium alloy (para [0029] and/or [0094]),
wherein the practitioner-shapeable distal end section is rendered linear elastic by the cold working step (para [0031]).
Shireman does not expressly disclose that the cold working is after applying the solder material.
However, Cornish teaches that cold working is after applying a solder material (col. 2, lines 56-67).
It would have been obvious to a skilled artisan to modify Shireman such that the cold working is after applying the solder material, in view of the teachings of Cornish, because such an order of events is consistent with the pre-tinning process disclosed in Shireman. That is, cold working after applying solder would prevent any foreign contamination from being deposited on the surface of Shireman’s device before solder is applied, but after it has been washed in the pre-tinning process. This would also result in the linear elastic deformation behavior after soldering, as required by the claim, since the cold-working is the mechanism that imparts the linear elastic deformation behavior and that process occurs after soldering.
Shireman does not expressly disclose wherein the practitioner-shapeable distal end section comprises a second cross-sectional dimension as a result of the cold working.
However, Muni teaches wherein the practitioner-shapeable distal end section comprises a second cross-sectional dimension as a result of the cold working (para [0037]).
It would have been obvious to a skilled artisan to modify Shireman wherein the practitioner-shapeable distal end section comprises a second cross-sectional dimension as a result of the cold working, in view of the teachings of Muni, for the obvious advantage of increasing the strength and hardness of the structure.
Shireman does not expressly disclose a distal linear elastic portion while the second, proximal portion of the distal portion retains superelastic behavior.
However, Hirshman teaches a distal linear elastic portion while a second, proximal portion retains superelastic behavior (para [0045]).
It would have been obvious to a skilled artisan to modify Shireman to include a distal linear elastic portion while the second, proximal portion of the distal portion retains superelastic behavior, in view of the teachings of Hirshman, for the obvious advantage providing different zones that have different properties that can be incorporated into the medical device in different ways (see para [0045] of Hirshman).
For claim 2, Shireman does not expressly disclose wherein the cold working includes at least one of flattening, stamping, rolling, or calendaring.
However, Muni teaches wherein cold working includes at least one of flattening, stamping, rolling, or calendaring (para [0040]-[0041]).
It would have been obvious to a skilled artisan to modify Shireman wherein the cold working includes at least one of flattening, stamping, rolling, or calendaring, in view of the teachings of Muni, because such a type of cold-working disclosed in Muni is suitable to achieve the results that Shireman wants to with its own more generic disclosure of cold working.
For claim 3, Shireman does not expressly disclose wherein the practitioner-shapeable distal end section exhibits 20% to 90% cold work.
However, Muni teaches wherein the practitioner-shapeable distal end section exhibits 20% to 90% cold work (para [0039]-[0041]).
It would have been obvious to a skilled artisan to modify Shireman wherein the practitioner-shapeable distal end section exhibits 20% to 90% cold work, in view of the teachings of Muni, because such a modification is a suitable way to create the linear pseudoelastic alloy disclosed in Shireman by removing any superelasticity that in Shireman’s practitioner-shapeable distal end section (see para [0040] of Muni).
For claim 4, Shireman does not expressly disclose wherein the practitioner-shapeable distal end section comprises a cold-worked microstructure that includes 40% to 50% cold work.
However, Muni teaches wherein the practitioner-shapeable distal end section comprises a cold-worked microstructure that includes 40% to 50% cold work (para [0039]-[0041]).
It would have been obvious to a skilled artisan to modify Shireman wherein the practitioner-shapeable distal end section comprises a cold-worked microstructure that includes 40% to 50% cold work, in view of the teachings of Muni, because such a modification is a suitable way to create the linear pseudoelastic alloy disclosed in Shireman by removing any superelasticity that in Shireman’s practitioner-shapeable distal end section (see para [0040] of Muni).
For claim 5, Shireman further discloses applying a second coating of solder to at least a portion of the practitioner-shapeable distal end section (as can be seen in Figs. 6-8), over the first layer of solder material (as can be seen in Figs. 6-8), the second coating of solder being a separately applied coating relative to the atraumatic cap (as can be seen in Figs. 6-8).
For claim 6, Shireman does not expressly disclose wherein after cold working, the practitioner-shapeable distal end section is in a martensitic phase.
However, Muni teaches wherein the cold working is in a martensitic phase (para [0040]).
It would have been obvious to a skilled artisan to modify Shireman wherein after cold working, the practitioner-shapeable distal end section is in a martensitic phase, in view of the teachings of Muni, because such a type of cold-working disclosed in Muni is suitable to achieve the results that Shireman wants to with its own more generic disclosure of cold working.
For claim 7, Shireman does not expressly disclose wherein the martensitic phase is preserved in forming the joint.
However, Muni teaches wherein the martensitic phase is preserved in forming the joint (core wire is first formed as shown in Figs. 3A-D, the step in Fig 3D during rolling being when the martensitic phase is established, see para [0040], then core wire is attached with solder to the coil 32, as disclosed in para [0034]).
It would have been obvious to a skilled artisan to modify Shireman wherein the martensitic phase is preserved in forming the joint, in view of the teachings of Muni, because such a type of cold-working disclosed in Muni is suitable to achieve the results that Shireman wants to with its own more generic disclosure of cold working.
For claim 8, Shireman does not expressly disclose wherein the martensitic phase is stabilized by cold working.
However, Muni teaches wherein the martensitic phase is stabilized by cold working (para [0040]).
It would have been obvious to a skilled artisan to modify Shireman wherein the martensitic phase is stabilized by cold working, in in view of the teachings of Muni, because such a type of cold-working disclosed in Muni is suitable to achieve the results that Shireman wants to with its own more generic disclosure of cold working.
For claim 9, Shireman further discloses wherein the elongate shaft member comprises stainless steel, a superelastic nickel-titanium alloy, or a combination thereof (para [0029]-[0036]).
For claim 10, Shireman does not expressly disclose wherein the practitioner-shapeable distal end section exhibits a yield stress in a range from 150 ksi to 225 ksi.
However, Muni teaches wherein the practitioner-shapeable distal end section exhibits a yield stress in a range from 150 ksi to 225 ksi (para [0039]-[0041]) (Examiner’s Note: Muni teaches a similarly structured device, formed from the same materials and cold worked between 40%-50%, which would result in a yield stress of about 150ksi-225ksi, and Applicant(s)’ disclosure cited cold working the distal end of the device providing the resulting yield strength, see MPEP 2113).
It would have been obvious to a skilled artisan to modify Shireman wherein the practitioner-shapeable distal end section exhibits a yield stress in a range from 150 ksi to 225 ksi, in view of the teachings of Muni, because such a modification is a suitable way to create the linear pseudoelastic alloy disclosed in Shireman by removing any superelasticity that in Shireman’s practitioner-shapeable distal end section (see para [0040] of Muni).
For claim 11, Shireman does not expressly disclose wherein the practitioner-shapeable distal end section exhibits a yield stress in a range from 150 ksi to 200 ksi.
However, Muni teaches wherein the practitioner-shapeable distal end section exhibits a yield stress in a range from 150 ksi to 200 ksi (para [0039]-[0041]) (Examiner’s Note: Muni teaches a similarly structured device, formed from the same materials and cold worked between 40%-50%, which would result in a yield stress of about 150ksi-200ksi, and Applicant(s)’ disclosure cited cold working the distal end of the device providing the resulting yield strength, see MPEP 2113).
It would have been obvious to a skilled artisan to modify Shireman wherein the practitioner-shapeable distal end section exhibits a yield stress in a range from 150 ksi to 200 ksi, in view of the teachings of Muni, because such a modification is a suitable way to create the linear pseudoelastic alloy disclosed in Shireman by removing any superelasticity that in Shireman’s practitioner-shapeable distal end section (see para [0040] of Muni).
For claim 13, Shireman further discloses wherein a core of the practitioner-shapeable distal end section surrounded by the first layer of solder material consists of the nickel titanium alloy which exhibits linear elastic deformation behavior (as can be seen in Figs. 1-8) (para [0029]-[0036]).
For claim 21, Shireman further discloses wherein a distal end of the helical coil section is distal of a proximal end of the atraumatic cap (as can be seen in Fig. 13).
For claim 26, Shireman further discloses wherein the metal hydroxide comprises a molten metal hydroxide (para [0082]).
For claim 27, Shireman further discloses wherein the metal hydroxide comprises an alkali metal hydroxide (para [0082]).
For claim 28, Shireman and Cornish do not expressly disclose wherein the practitioner-shapeable distal end section exhibits a yield stress from 100 ksi to 300 ksi.
However, Muni teaches wherein a practitioner-shapeable distal end section exhibits a yield stress from 100 ksi to 300 ksi (para [0039]-[0041]) (Examiner’s Note: Muni teaches a similarly structured device, formed from the same materials and cold worked between 40%-50%, which would result in a yield stress of about 150ksi-200ksi, and Applicant(s)’ disclosure cited cold working the distal end of the device providing the resulting yield strength, see MPEP 2113).
It would have been obvious to a skilled artisan to modify Shireman wherein the practitioner-shapeable distal end section exhibits a yield stress from 100 ksi to 300 ksi, in view of the teachings of Muni, because such a modification is a suitable way to create the linear pseudoelastic alloy disclosed in Shireman by removing any superelasticity that in Shireman’s practitioner-shapeable distal end section (see para [0040] of Muni).
Claim(s) 22-24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shireman in view of Cornish, Muni, and Hirshman, and further in view of U.S. Patent Application Publication No. 2013/0006149 to Purtzer.
For claim 22, Shireman, Cornish, Muni, and Hirshman do not expressly disclose wherein the metal hydroxide comprise at least one of potassium hydroxide or sodium hydroxide.
However, Purtzer teaches wherein the metal hydroxide comprise at least one of potassium hydroxide or sodium hydroxide (para [0050] and [0053]).
It would have been obvious to a skilled artisan to modify Shireman wherein the metal hydroxide comprise at least one of potassium hydroxide or sodium hydroxide, in view of the teachings of Purtzer, for the obvious advantage of forming an oxide-free surface that the pre-tinning process can be applied to (see para [0050] and [0053] of Purtzer).
For claim 23, Shireman, Cornish, Muni, and Hirshman do not expressly disclose wherein the first layer of solder material applied to the practitioner-shapeable distal end section has a melting point temperature in a range of 150 °C to 350 °C.
However, Purtzer teaches wherein the first layer of solder material applied to the practitioner-shapeable distal end section has a melting point temperature in a range of 150 °C to 350 °C (para [0054]).
It would have been obvious to a skilled artisan to modify Shireman wherein the first layer of solder material applied to the practitioner-shapeable distal end section has a melting point temperature in a range of 150 °C to 350 °C, in view of the teachings of Purtzer, because such a temperature is a suitable temperature that balances efficient melting and flow of the solder without too much oxidation.
For claim 24, Shireman, Cornish, Muni, and Hirshman do not expressly disclose wherein the first layer of solder material applied to the practitioner-shapeable distal end section has a melting point temperature in a range of 280 °C to 300 °C.
However, Purtzer teaches wherein the first layer of solder material applied to the practitioner-shapeable distal end section has a melting point temperature in a range of 280 °C to 300 °C (para [0054]).
It would have been obvious to a skilled artisan to modify Shireman wherein the first layer of solder material applied to the practitioner-shapeable distal end section has a melting point temperature in a range of 280 °C to 300 °C, in view of the teachings of Purtzer, because such a temperature is a suitable temperature that balances efficient melting and flow of the solder without too much oxidation.
Claim(s) 25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shireman in view of Cornish, Muni, and Hirshman, and further in view of U.S. Patent Application Publication No. 2011/0098648 to Kato.
For claim 25, Shireman, Cornish, Muni, and Hirshman do not expressly disclose wherein the atraumatic cap comprises a eutectic alloy.
However, Kato teaches wherein the atraumatic cap comprises a eutectic alloy (para [0159]).
It would have been obvious to a skilled artisan to modify Shireman wherein the atraumatic cap comprises a eutectic alloy, in view of the teachings of Kato, for the obvious advantage of controlling the melting point of the cap.
Response to Arguments
Applicant’s arguments filed 4/15/26 have been fully considered.
With respect to the objection to the specification, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn.
With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn.
With respect to the 103 rejections, Applicant’s arguments are predicated on the newly amended claim language. However, these arguments are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response.
Conclusion
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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