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.
Notice of Amendment
In response to the amendment(s) filed on 1/27/26, amended claim(s) 1, 3-4, 6, 10-11, 13, 23-24, and 28 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Specification
The amendment filed 1/27/26 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the newly amended claim language to para [0033].
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-11, 13, and 21-28 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
For claim 1, the claim language “substantially linear stress-strain response” (line 15) is ambiguous. How linear does the stress-strain response need to be to be considered “substantially linear”? The claim is examined as meaning “linear stress-train response.”
For claim 1, the claim language “without substantial heating of the practitioner-shapeable distal end section” (lines 19-20) is ambiguous. How much lack of heating is necessary to be considered without “substantial” heating? The claim is examined as meaning “without heating of the practitioner-shapeable distal end section.”
For claim 23, the claim language “about 150 °C to about 350 °C” is ambiguous. How close to 150 °C and 350 °C is “about” 150 °C and 350 °C? Does 149.99 and 349.99 get included? Does 149.9 and 349.9 get included? Does 149 and 349 get included? The claim is examined as “150 °C and 350 °C.”
For claim 24, the claim language “about 280 °C to about 300 °C” is ambiguous. How close to 280 °C and 300 °C is “about” 280 °C and 300 °C? Does 279.99 and 299.99 get included? Does 279.9 and 299.9 get included? Does 279 and 299 get included? The claim is examined as “280 °C and 300 °C.”
Dependent claim(s) 2-11, 13, and 21-28 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-11, 13, and 21-28 is/are rejected under 35 U.S.C. 112(b).
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”) and U.S. Patent Application Publication No. 2002/0062092 to Muni et al. (hereinafter “Muni”).
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 pseudoelastic deformation behavior (“nickel-titanium alloy such as linear elastic or superelastic (i.e., pseudoelastic) nitinol,” para [0029]) (also see para [0030]-[0036]), having a stress-strain curve without any flat plateau stresses (“…it does not display a substantial ‘superelastic plateau’ or ‘flag region’ in its stress/strain curve,” para [0031]) without a phase transformation or onset of stress-induced martensite (Examiner’s Note: this limitation being construed in view of para [0006] of Applicant(s)’ specification as originally filed, which states that linear pseudoelastic nitinol is capable of such) (para [0031]-[0032]),
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]) without heating of the practitioner-shapeable distal end section (para [0076], examples such as adhesive bonding and crimping don’t require heat), 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 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]).
Shireman does not expressly disclose that the cold working is following applying the solder material.
However, Cornish teaches that cold working is following 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 following 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.
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.
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 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 soldered joint.
However, Muni teaches wherein the martensitic phase is preserved in forming the soldered 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 soldered 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 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 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 and Muni, and further in view of U.S. Patent Application Publication No. 2013/0006149 to Purtzer.
For claim 22, Shireman, Cornish, and Muni 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, and Muni 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 about 150 °C to about 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 about 150 °C to about 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 about 150 °C to about 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, and Muni 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 about 280 °C to about 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 about 280 °C to about 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 about 280 °C to about 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 and Muni, and further in view of U.S. Patent Application Publication No. 2011/0098648 to Kato.
For claim 25, Shireman, Cornish, and Muni 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 1/27/26 have been fully considered.
With respect to the 112(a) rejections, Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn. It is noted that the specification does not need to be amended to overcome the previous 112(a) rejection.
With respect to the 112(b) rejections, Applicant’s amendments and arguments have overcome some of the rejections. The rejections that are maintained were noted traversed in the response. Additionally, new rejections have been necessitated in view of the newly amended claim language..
With respect to the 103 rejections, the new rejection is in response to the newly amended claim language. Shireman teaches the newly amended first and second portions according to the citations listed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791