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 .
Response to Amendment
The amendments to the claims filed 11 August 2026 have been entered. Claims 1, 3-4, and 6-8 are pending; claims 2, 5, and 9 are newly canceled. The amendments to the claims have overcome each and every rejection under 35 U.S.C. 112(b) previously applied in the office action mailed 15 April 2026.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: second wire feeding mechanism in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. See paragraph 0034 of the instant specification which describes “two braiders (first wire feeding mechanism 200 and second wire feeding mechanism 202)”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(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.
Claim(s) 1, 3-4, 6-8 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Warnock (US 20080262471 A1).
Regarding claim 1, Warnock teaches a braided structure comprising:
a shaft (Paragraph 0022, 0036, 0047; core 695);
a plurality of first wires wound in a spiral shape around an axis of the shaft (Filaments 252; Figs. 4 and 9A-9B; paragraph 0029—at least half of the plurality of filaments 252 is continuous throughout the length of the reinforcing layer 250 and shifts from the braided configuration to the coiled configuration in transition region 258; paragraph 0034—one bobbin carrier for each bobbin of filament used to form the braided portion of the reinforcing layer…the reinforcing layer of a braided and coiled catheter body may be formed from any number of filaments…may pay out multiple filaments, e.g., where two filaments are paid out from each bobbin…); and
a second wire (Filaments 252; paragraph 0029, 0034) wound around the shaft in a direction opposite to that of the plurality of first wires in a first portion (Fig. 4, 9B—braided portion 254/860; paragraph 0028-0029, 0041—a braided configuration),
and wound around the shaft in a direction identical to that of the plurality of first wires in a second portion (Fig. 4, 9B—coiled portion 256/865; paragraph 0028-0029, 0041--and shifts from the braided configuration to the coiled configuration in transition region 258), wherein
the second wire is provided with a changing portion at which a rotation direction of a spiral changes between the first portion and the second portion (Fig. 4—transition region 258; Fig. 9B—see transition between braided and coiled sections; Paragraph 0028-0029, 0033-0036, 0040-0044-- first track moves bobbin carriers 625 in a clock-wise direction. A second track moves bobbin carriers 630 in a counter clock-wise direction. This movement of bobbin carriers 625 in a direction opposite of carriers 630 causes the carriers to pass inwardly and outwardly around each other to interlace the attached filaments. This interlacing of filaments forms the braided portion 660 of the reinforcing layer…the reinforcing layer transitions from a braided portion to a coiled portion with continuous filaments… the braided portion 860 of the reinforcing layer is formed on the core 695 in the same manner as braided section 660. However, to form coiled portion 865 bobbin carriers 625, 630 move from horn gears 615, 620 to the circular coil-forming pathway 875 via radial pathways 670. Once the bobbin carriers are positioned in the coil pathway, the bobbin carriers move along the circular coil pathway in the direction of arrow B, impelled by a rotational drive mechanism (not shown) that may engage bobbin carriers 625, 630 from either above or below horizontal track plate 610. In this embodiment, as core 695 moves upward relative to the circular movement of bobbin carriers 625, 630, a coil portion 865 is formed wherein ail of the filaments are wrapped around the core in the same direction. As illustrated, the coil portion 865 is formed as the bobbin carriers move in a clock-wise direction.), and
the plurality of first wires are not provided with a changing portion at which a rotation direction of a spiral changes between the first portion and the second portion (Fig. 4, 9B—the direction of one selection of filaments does not change; paragraph 0028-0029, 0033-0036, 0040-0044).
Regarding claim 3, Warnock teaches the braided structure according to claim 1. Warnock additionally teaches wherein the second wire does not have any ends present in at least the first portion and the second portion (see filaments in each region, where no ends are present and where during manufacture the bobbins continue to wind throughout the full length of the shaft, Fig. 4 and 9A-9B; paragraph 0029—at least half of the plurality of filaments 252 is continuous throughout the length of the reinforcing layer 250…).
Regarding claim 4, Warnock teaches the braided structure according to claim 1. Warnock additionally teaches wherein the plurality of first wires and the second wire form a wire layer around the shaft (Reinforcing layer 250; paragraph 0028-0029), and
a thickness of the wire layer in the first portion is thicker than a thickness of the wire layer in the second portion (As each filament has a thickness, the wire layer would be thicker in the first portion where the first and second filament overlap as the point of overlap would have the thickness of both filaments together, while the second region would have a thickness of only one filament at any location, Fig. 4, 9A-9B).
Regarding claim 6, Warnock teaches the braided structure according to claim 1. Warnock additionally teaches wherein a winding interval of the plurality of first wires differs between the first portion and the second portion (Paragraph 0036-- Those with skill in the art will understand that the pitch of the braid and the coil may be determined by how last core 695 moves in the upward direction in relation to the rotation speed of horn gears 615, 620, which defines the speed at which the carriers revolve in their sinusoidal path around core 695. In one embodiment, the pitch of the braid is altered along the length of a catheter by adjusting the rate of speed at which core 695 is moving longitudinally relative to the rotation speed of horn gears 615, 620).
Regarding claim 7, Warnock teaches a braided structure comprising:
a first portion in which a plurality of first wires and a second wire are wound around a shaft so as to cross each other (Fig. 4, 9B—braided portion 254/860; paragraph 0028-0029, 0041—a braided configuration; paragraph 0034—one bobbin carrier for each bobbin of filament used to form the braided portion of the reinforcing layer…the reinforcing layer of a braided and coiled catheter body may be formed from any number of filaments…may pay out multiple filaments, e.g., where two filaments are paid out from each bobbin…);
a second portion in which the plurality of first wires and the second wire are wound around the shaft in an identical direction (Fig. 4, 9B—coiled portion 256/865; paragraph 0028-0029, 0041--and shifts from the braided configuration to the coiled configuration in transition region 258); and
a changing portion disposed between the first portion and the second portion and at which: a rotation direction of a spiral of the second wire is reversed (Fig. 4—transition region 258; Fig. 9B—see transition between braided and coiled sections; Paragraph 0028-0029, 0033-0036, 0040-0044-- first track moves bobbin carriers 625 in a clock-wise direction. A second track moves bobbin carriers 630 in a counter clock-wise direction. This movement of bobbin carriers 625 in a direction opposite of carriers 630 causes the carriers to pass inwardly and outwardly around each other to interlace the attached filaments. This interlacing of filaments forms the braided portion 660 of the reinforcing layer…the reinforcing layer transitions from a braided portion to a coiled portion with continuous filaments… the braided portion 860 of the reinforcing layer is formed on the core 695 in the same manner as braided section 660. However, to form coiled portion 865 bobbin carriers 625, 630 move from horn gears 615, 620 to the circular coil-forming pathway 875 via radial pathways 670. Once the bobbin carriers are positioned in the coil pathway, the bobbin carriers move along the circular coil pathway in the direction of arrow B, impelled by a rotational drive mechanism (not shown) that may engage bobbin carriers 625, 630 from either above or below horizontal track plate 610. In this embodiment, as core 695 moves upward relative to the circular movement of bobbin carriers 625, 630, a coil portion 865 is formed wherein ail of the filaments are wrapped around the core in the same direction. As illustrated, the coil portion 865 is formed as the bobbin carriers move in a clock-wise direction.), and
a rotation direction of a spiral of the plurality of first wires is not changed (Fig. 4, 9B—the direction of one selection of filaments does not change; paragraph 0028-0029, 0033-0036, 0040-0044), wherein
the first portion, the second portion, and the changing portion are provided along an axis of the shaft (Paragraph 0022, 0036, 0047; core 695).
Regarding claim 8, Warnock teaches a method for manufacturing a braided structure (Paragraph 0040-0044, 0046-0051--method), the method comprising:
winding a first wire in a spiral shape around an axis of a shaft (Paragraph 0022, 0036, 0047-0048-- At least a portion of the plurality of filaments that form braided portion 253, 354, 660, 860 are used to form at least one coiled portion 256, 356, 665, 865 surrounding the core (Block 1140)…; core 695; Figs. 4, 9A-9B);
winding a second wire around the shaft in a direction opposite to that of the first wire by rotating a second wire feeding mechanism around the axis of the shaft (Fig. 4, 9A-9B—braided portion 254/860 which is formed by rotation of wire feeding mechanisms around the axis of the shaft; paragraph 0028-0029, 0041—a braided configuration; paragraph 0028-0029, 0033-0036, 0040-0044, 0047-0051-- first track moves bobbin carriers 625 in a clock-wise direction. A second track moves bobbin carriers 630 in a counter clock-wise direction. This movement of bobbin carriers 625 in a direction opposite of carriers 630 causes the carriers to pass inwardly and outwardly around each other to interlace the attached filaments. This interlacing of filaments forms the braided portion 660 of the reinforcing layer…);
changing a rotation direction of a spiral of the second wire by changing a rotation direction of the second wire feeding mechanism, after the winding of the second wire in the direction opposite to that of the first wire (Fig. 4—transition region 258; Fig. 9A-9B—see transition between braided and coiled sections, where the second wire is changed to rotate in the same direction as the first wire to form a coil after previously winding in the direction opposite the first wire to form a braid; Paragraph 0028-0029, 0033-0036, 0040-0044, 0047-0051-- the reinforcing layer transitions from a braided portion to a coiled portion with continuous filaments… the braided portion 860 of the reinforcing layer is formed on the core 695 in the same manner as braided section 660… the at least one braided portion is transformed to the at least one coiled portion through a transition region 258, 358…); and
winding the second wire around the shaft in a direction identical to that of the first wire by rotating the second wire feeding mechanism around the axis of the shaft (Fig. 4, 9A-9B—coiled portion 256/865 formed by rotating wire feeding bobbins around the axis of the shaft; paragraph 0028-0029, 0040-0044, 0047-0051--and shifts from the braided configuration to the coiled configuration in transition region 258…to form coiled portion 865 bobbin carriers 625, 630 move from horn gears 615, 620 to the circular coil-forming pathway 875 via radial pathways 670. Once the bobbin carriers are positioned in the coil pathway, the bobbin carriers move along the circular coil pathway in the direction of arrow B, impelled by a rotational drive mechanism (not shown) that may engage bobbin carriers 625, 630 from either above or below horizontal track plate 610. In this embodiment, as core 695 moves upward relative to the circular movement of bobbin carriers 625, 630, a coil portion 865 is formed wherein ail of the filaments are wrapped around the core in the same direction. As illustrated, the coil portion 865 is formed as the bobbin carriers move in a clock-wise direction.).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that the newly cited reference, Warnock, discloses that each grouping of first or second wires may have any number of wires in the group, but that only one group of wires changes direction when transitioning from a braided configuration to a coiled configuration such that only one group of wires includes a changing portion. Warnock additionally describes altering the rotation direction of wire feeding mechanisms from a counter clock-wise direction to a clock-wise direction.
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 ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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