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 .
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.
Claims 42-49 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.
In Claims 42-44, the claim limitation "a method of making a vascular access wire, wherein the vascular access wire comprises a core member, the method comprises" renders the claim indefinite because the statutory category is unclear. It is unclear because the claims are first written as a method claim (“a method for making a vascular access wire”), then as apparatus claim (“the vascular access wire comprises a core member”), then as a method claim (“a method comprising…”). For purposes of examination, the claims are a method claim. Due to the rejection of the independent claim, the dependent claims are also rejected because they are failing to cure the deficiencies as stated in the independent claim.
In Claim 45, the claim limitation “core member is allowed to buckle or bend” renders the claim indefinite because the limitation is unclear. It is unclear how buckle is defined and distinct from “bend” because buckle can mean either “fastening” or “bend”. If buckle is defined as “fastening,” what does it mean for the core member to “fasten”? Or is buckle defined as “bending”? For purposes of examination, the claim limitation is interpreted as synonymous.
In Claim 46, the claim limitation “the distal tip” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a distal tip.”
In Claim 48, the claim limitation “the pushing follows the shaping” renders the claim indefinite because the limitation is unclear. It is unclear whether the pushing is causing the shaping of the distal tip of the core member or shaping a different element. The claims discuss the pushing of the core member, mentioned in claim 44, follows the shaping of the distal tip, mentioned in claim 47. Paragraph 0053 within the specification clarifies the pushing causes the shaping of the distal tip of the core member. For purposes of examination, the claim limitation is interpreted as “the pushing causes the shaping of the distal tip of the core member.” Due to the rejection of the independent claim, the dependent claims are also rejected because they are failing to cure the deficiencies as stated in the independent claim.
Claim Rejections - 35 USC § 102
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.
Claims 42 – 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horst et al. (US 20220105314 A1).
Regarding Claim 42, Horst discloses a method of making a vascular access wire (abstract), wherein the vascular access wire (elongated body – element 104; Figs. 2 and 4; [0033]) comprises a core member (core wire – element 120; Figures 2-6; [0033]), the method comprising forming a hinge (proximal portion – element 112; Figs. 4-6; [0040]) in the core member at least in part by fixedly altering a straight aligned length of the core member (Figs. 2 and 6; [0040 - The proximal portions 106-112 of the core wire 120 need to have sufficient stiffness (greater than the narrow segment 130) such that the shape of the core wire 120 influences the stylet 100 after assembly and the stylet 100 does not buckle too easily during insertion]).
Regarding Claim 43, Horst discloses a method of making a vascular access wire (abstract), vascular access wire (elongated body – element 104; Figs. 2 and 4; [0033]) comprises a core member (core wire – element 120; Figures 2-6; [0033]), the method comprising forming a hinge (proximal portion – element 112; Figs. 4-6; [0040]) in the core member at least in part by fixedly deforming a portion of the core member into a curved length ([0040 - the stylet 100 has a stiffness profile such that the narrow segment 130 of the fifth portion 114 may be the first location along the length of the core wire 120 to buckle which may improve the insertion angle of the distal tip 116 and maintain pushability of the assembly]).
Regarding Claim 44, Horst discloses a method of making a vascular access wire(abstract), vascular access wire (elongated body – element 104; Figs. 2 and 4; [0033]) comprises a core member (core wire – element 120; Figures 2-6; [0033]), the method comprising forming a hinge (proximal portion – element 112; Figs. 4-6; [0040]) in the core member at least in part by pushing the core member along a chosen pushing axis against a surface perpendicular (catheter – element 150; Fig. 6; [0043]) to the pushing axis ([0040 - the stylet 100 has a stiffness profile such that the narrow segment 130 of the fifth portion 114 may be the first location along the length of the core wire 120 to buckle which may improve the insertion angle of the distal tip 116 and maintain pushability of the assembly]).
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Regarding Claim 45, Horst discloses the method according to claim 44, wherein the pushing is performed while a chosen unsupported length of core member is allowed to buckle or bend transversely to the pushing axis (Figs. 13a-b; [0040], [0043], [0053]; [Examiner’s note, the “pushing” is performed by the user. The unsupported length occurs when the stylist (400) extends out of the catheter (450) and causes the stylist, which includes the core wire, to bend and buckle, as shown in figures 13a-b. Please refer to Annotated Figure 1 for further clarification.]) and a supported length of core member proximally to the unsupported length is prevented from buckling or bending transversely to the pushing axis (Figs. 13a-b; [0040], [0043], [0053]; [Examiner’s note, the support length occurs when the core wire is within the catheter, which prevents the core wire to bend and buckle]).
Annotated Figure 1 | The core member is within the stylist (400). When the stylist is within the catheter (450), the core member is within the supported length. When the stylist is extended outside of the catheter (450), the core member is within the unsupported length.
Regarding Claim 46, Horst discloses the method according to claim 45, wherein a portion of the distal tip (distal tip – elements 116 and 416; [Examiner’s note, the distal tip of 116 and 416 are the same. This is discussed within [0053 - FIGS. 13A-B illustrate a stylet 400 and a catheter 450 according to a sixth embodiment of the present invention. The stylet 400 may have similar features as discussed above with regard to at least one of the stylets 100, 100′, 200, 300 and incorporated herein (unless otherwise indicated)]) is prevented from shifting transversely to the pushing axis ([0043], [0053]; [Examiner’s note, the frictional properties along the length of the tubular body, which comprises the core member and the distal tip, decreases the tubular body from shifting transversely within the catheter when the user is performing the pushing action.]) and/or is supported in a niche surrounded by the surface [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
Regarding Claim 47, Horst discloses the method according to claim 44, further comprising shaping a distal tip of the core member (Fig. 14A-C; [0053 - a stylet 400′ received in a catheter 450′ may include a distal segment 436′ including a plurality of flexible members 436a′ (e.g., wires) having a curved or looped configuration forming a basket. The flexible members 436a′ may extend distal from a tubular portion 436b′ and be joined at a distal tip of the stylet 400′ and/or be looped back proximally to the tubular portion 436b′.]).
Regarding Claim 48, Horst discloses the method according to claim 47, wherein the pushing follows the shaping ([0040], [0043], [0053]; [Examiner’s note, the “pushing” is performed by the user. Once the distal tip of the core wire is extended out of the catheter, the distal releases the distal segment and creates a shape.]).
Regarding Claim 49, Horst discloses the method according to claim 47, wherein the shaping comprises forming a crank which includes a spherical-dome-shaped portion having a distally pointing apex (distal tip – elements 116 and 416; Fig. 13A-B; [0044 - the distal tip 116 may be atraumatic (e.g., rounded and/or tapered edges) to reduce trauma on the vascular tissue]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Friday: 9AM to 5PM EST.
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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