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 .
Note: all citations with respect to the specification of present application are citing the paragraph numbers in the Pre-Grant Publication US 2025/0249212 A1.
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 1, 2, 4, 5, 9, 10, 13 – 15, 17, 28 – 38, 40, 41, 44 – 46 and 59 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.
Claim 1 recites limitation “a second magnetic susceptibility that is different than, preferably greater than, the first magnetic susceptibility”, which includes a preference of narrower range. It is unclear whether the recited narrower range (“greater than”) is a limitation with the term “preferably”.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted with the broad range (“different than”).
Claim 10 recites limitation “a thickness in the range of about 0.03 mm to about 0.15 mm and a width in the range of about 0.25 mm to about 0.5 mm”; claim 34 recites limitation “a magnetic susceptibility not exceeding about 2000 ppm”; claim 35 recites limitation “a magnetic susceptibility of at least about 7000 ppm”; and claim 44 recites limitation “a wall thickness in the range of about 0.25 mm to about 0.35 mm”.
The term “about” used in above limitations are relative term to describe approximation, which renders claim indefinite. The corresponding disclosure in the specification of present application is recited as: “The flat wire of the a coil providing reinforcement member 228, in preferred forms, will have a thickness (which becomes disposed in the radial direction) in the range of about 0.03 mm to about 0.15 mm and a width in the range of about 0.25 mm to about 0.5 mm. The flat wire is preferably formed of a metal, and more preferably a metal having a magnetic susceptibility not exceeding about 3000 ppm, or not exceeding about 2000 ppm, or not exceeding about 1000 ppm, and in some forms in the range of about 1 ppm to about 3000 ppm, in the range of about 1 ppm to about 2000 ppm, or in the range of about 1 ppm to about 1000 ppm” in [0079]; “the passive MRI marker-forming material for the plug marker(s) will have a magnetic susceptibility of at least about 500 ppm, or at least about 2000 ppm, or at least 7000 ppm, and typically in the range of about 500 ppm to about 1,000,000 and more preferably in the range of about 7000 ppm to about 100,000 (these values will be understood as positive values)” in [0085]; “In some forms, the wall thickness of the elongate member 210 including the inner tube 250, the reinforcement member 228, and the outer tube 250 is about 0.25 mm to about 0.35 mm” in [0082].
The above disclosure does not define a certain number (e.g. variation %) for the approximation. Without knowing the boundary of approximation, it is unclear within which range can be considered as “about”.
Thus, the above limitations render claims indefinite. For the purpose of examination, the above limitations are interpreted as any reasonable ranges.
Claim 30 recites limitation “wherein the elongate member includes a thermoformed polymeric material providing a distal tip of the elongate member extending distally beyond a distal end of the inner tubular member; optionally, wherein the thermoformed polymeric material is bonded to the outer surface of the second longitudinal segment of the inner tubular member”. The limitations after term “optionally” is not alternative limitation about the thermoformed polymeric material, but an optional condition describing preference. It is unclear applicant intends to claim the specific material processing or not, with the term “optionally”.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable scope.
Claim 46 recites limitation “the second material having a magnetic susceptibility that is different than, preferably greater than, the first magnetic susceptibility”, which includes a preference of narrower range. It is unclear whether the recited narrower range (“greater than”) is a limitation with the term “preferably”.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted with the broad range (“different than”).
Therefore, claim 1, 10, 30, 34, 35, 44, 46 and all corresponding dependent claims are ejected under 35 U.S.C. 112(b) as being indefinite.
Allowable Subject Matter
Claim 1, 2, 4, 5, 9, 10, 13 – 15, 17, 28 – 38, 40, 41, 44 – 46 and 59 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Jalgaonkar et al. (US 2019/0366036 A1; published on 12/05/2019) (hereinafter “Jalgaonkar”), Flores et al. (US 2017/0106171 A1; published on 04/20/2017) (hereinafter “Flores”) and Anttila et al. (US 2023/0248241 A1; published on 08/10/2023) (hereinafter “Anttila”) are cited as most relevant prior arts to the claimed invention.
The claimed invention requires a specific positional and material combination of reinforcement member and MRI marker within an elongated instrument. The instrument must have two layered wall and the reinforcement member must be positioned between those two layers. In addition, the reinforcement member and the marker must have different magnetic susceptibilities. There are many key variables to determine the magnetic susceptibility of a component. Even with same material, the magnetic susceptibility can be different according to crystal structure, impurities, processing history, etc. Thus, the certain “magnetic susceptibility” is required by the invention.
Jalgaonkar teaches a catheter with similar structure (Fig.2). The catheter wall is in layered structure and a support structure is sandwiched between two layers (Fig.2; [0078]). A marker is also taught (Fig.2; [0089]). However, the catheter is not used under MRI and the marker is a radiopaque marker ([0088]). There is no teaching about magnetic susceptibility of the support structure and marker.
Flores teaches an MRI-compatible guidewire with a close structure (Fig.1 and 2). An elongate spring coil of non-ferromagnetic material is taught as the reinforcement member (Fig.2; [0041]), but the spring coil is not positioned between two layers of external wall, since the external wall is not in layered structure. A passive MRI-visible marker is also taught ([0045]). However, there is no teaching about the comparison of magnetic susceptibility for the spring coil or marker.
Anttila teaches a medical device used under MRI. The medical device is in tubular structure with several layers (Fig.14; [0074]) and MRI markers ([0075]). In addition, it is taught that the elongated member (the outer wall) and the MRI markers are having different magnetic susceptibility ([0077]). However, the elongated member is not functioned as the claimed reinforcement member, and the position of elongated member is at the most outer position not somewhere between two layers.
Thus, the cited prior arts and other search results in combination fails to teach all limitations as recited in the claims.
Regarding independent claim 1, Jalgaonkar, Flores, Anttila and other search results collectively neither teach nor fairly well suggest a medical device, comprising: “a reinforcement member disposed within the circumferential wall between the inner tubular member and the outer tubular member, extending along a length of the elongate member, and formed of a first material and having a first magnetic susceptibility; and a passive MRI marker attached to the elongate member and formed of a second material having a second magnetic susceptibility that is different than, preferably greater than, the first magnetic susceptibility”, in combination with other limitations as recited in claim 1.
Claim 2, 4, 5, 9, 10, 13 – 15, 17, 28, 29 and 59 are dependent on claim 1, and therefore inherently include the allowable subject matter as identified above.
Regarding independent claim 30, Jalgaonkar, Flores, Anttila and other search results collectively neither teach nor fairly well suggest a medical device, comprising: “a reinforcement member disposed within the circumferential wall between the inner tubular member and the outer tubular member, extending along a length of the elongate member, and formed of a first material and having a first magnetic susceptibility not exceeding 3000 ppm; a passive MRI marker attached to the elongate member and formed of a second material having a second magnetic susceptibility that is greater than the first magnetic susceptibility;” “wherein the outer tubular member is formed of a thermoformable polymeric material that has been thermoformed against and around the reinforcement member and against an outer surface of the inner tubular member”, in combination with other limitations as recited in claim 30.
Claim 31 – 38, 40, 41, 44 and 45 are dependent on claim 30, and therefore inherently include the allowable subject matter as identified above.
Regarding independent claim 46, Jalgaonkar, Flores, Anttila and other search results collectively neither teach nor fairly well suggest a method for making a medical device, comprising: “positioning an elongate reinforcement member around an elongate polymeric inner tubular member, the reinforcement member being formed from a first material having a first magnetic susceptibility; positioning an elongate thermoformable polymeric outer tubular member around the reinforcement member and inner tubular member;” “attaching a passive MRI marker formed from a second material to the reinforced tubular structure, the second material having a magnetic susceptibility that is different than, preferably greater than, the first magnetic susceptibility”, in combination with other limitations as recited in claim 46.
Conclusion
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/CHAO SHENG/ Primary Examiner, Art Unit 3797