DETAILED ACTION
Allowable Subject Matter
Claims 29-32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claim(s) 29 limits a surgical method including pushing the guidewire tip against a vessel wall, triggering a buckling or bending, advancing the guidewire, and allowing the tip to flex / realign with the rear of the guidewire which is not anticipated nor made obvious by the prior art. While Reynolds teaches the structure of claim(s) 1, Reynolds does not teach the particularly claimed navigational procedure of claim(s) 29. The state of the art at the time of filing does not remedy Reynolds, instead only more generally suggesting navigating in guidewires in blood vessels — not the specific pushing to bending / buckling of the guidewire and then the allowing to flex / realign limited in claim(s) 29. Claim(s) 30-32 are indicated as allowable in dependent form by virtue of their dependence on claim(s) 29.
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 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.
Examiner notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1, 2, 14-17, 21-25, and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reynolds (US 20040167436 A1).
For claim 1, Reynolds teaches A vascular access guidewire, [preferable embodiment of Fig(s). 1, consider also Fig(s). 14-17] comprising:
comprising an elastic core member [10] ending with a guidewire tip segment [entirety of portion shown in Fig(s). 1 constitute(s), under BRI, a form of a tip ‘segment’] comprising a widening [26] ,
a guidewire tip rear portion [any one or more of portions of 10 proximal to 26 such as 16, 18, 20, 22, or distal portion of 24 (e.g., distalmost third or half of 24)] extending distally to the widening, [Fig(s). 1]
and a guidewire tip front portion [28] thicker than the guidewire tip rear portion extending distally from the widening; [Fig(s). 1]
wherein the guidewire tip rear portion includes a flexing portion [whole of 24 or portion of 24 proximal to distalmost portion / half of 24] configured to cause localized buckling and/or bending for inclining the guidewire tip front portion relative to the guidewire tip rear portion, in the beveled opening, when the core member is axially compressed; [stiffness / flexibility (i.e., “bending”) control via tapering or use of a ‘ribbon’ intermediate section for a ‘tip’ portion of guidewire 10 is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Reynolds — see esp. ¶¶37-45]
wherein the flexing portion includes a curved length along which the core member is fixedly deviated laterally relatively to straight aligned portions of the core member proximally and distally adjacent to the curved length. [whole / portion of 24 in Fig(s). 1 would have a ‘curved’ length which is laterally deviated relative to proximal portions of 10 during navigation through tortuous anatomy as per ¶2 in view of ¶¶37-45 which constitute(s), under BRI, a form of a “fixed” deviation in that during use the curve of the core wire occurs in a fixed length of the wire][consider also specifically ¶39 which specifies that the core wire can be tapered in a ‘curvilinear fashion’ which constitute(s), under BRI, a form of fixed lateral deviation in a curved length]
For claim 2, Reynolds teaches The guidewire according to claim 1,
wherein the core member comprises of a guidewire proximal segment extending distally to a first narrowing, [16 extending onto 18]
a guidewire intermediate segment [20] thinner than the guidewire proximal segment extending distally from the first narrowing to a second narrowing, [22]
and the guidewire tip segment extending distally from the second narrowing. [Fig(s). 1]
For claim 14, Reynolds teaches The guidewire according to claim 1,
wherein the flexing portion is configured with resistance to bending and/or buckling smaller than the straight aligned portions of the core member proximally and distally adjacent to the curved length. [¶¶37-45]
For claim 15, Reynolds teaches The guidewire according to claim 1,
wherein the core member is deviated in at least one axis along the curved length. [whole / portion of 24 in Fig(s). 1 would have a ‘curved’ length which is laterally deviated relative to proximal portions of 10 during navigation through tortuous anatomy as per ¶2 in view of ¶¶37-43]
For claim 16, Reynolds teaches The guidewire according to claim 1,
wherein the core member forms a coil [46] along the curved length.
For claim 17, Reynolds teaches The guidewire according to claim 1,
wherein the flexing portion includes at least one localized lateral recess. [tapers 22 and 26 form at least a type of recess in Fig(s). 1, see also Fig(s). 14-17]
For claim 21, Reynolds teaches A method of producing the guidewire according to claim 2, comprising:
forming the first narrowing, the second narrowing, the guidewire tip rear portion and the widening on a pre-machined wire; [¶42]
and fixedly altering a straight aligned length of the guidewire tip rear portion to form the flexing portion. [¶42]
For claim 22, Reynolds teaches The method according to claim 21,
wherein the forming includes grinding the pre-machined wire. [¶42]
For claim 23, Reynolds teaches The method according to claim 21,
wherein the fixedly altering includes fixedly deforming the straight aligned length into a curved length, along which the core member is fixedly deviated laterally relatively to straight aligned portions of the core member proximally and distally adjacent to the curved length. [stamping / grinding of tapers in ¶42 is a form of curving; more generally, use in tortuous anatomy per ¶2 in ¶¶37-45 is a form of deforming a portion such as 24 in Fig(s). 1 into a ‘curved’ length (i.e., curved during use)]
For claim 24, Reynolds teaches The method according to claim 21,
wherein the fixedly altering includes forming at least one lateral recess or slit from the straight aligned length by way of subtractive manufacturing. [grinding of tapers / differing diameters of core wire in Fig(s). 1 in ¶42]
For claim 25, Reynolds teaches The method according to claim 21, comprising connecting a cylindrical coiled member [46] between the first narrowing and the widening of the core member. [Fig(s). 5-9]
For claim 33, Reynolds teaches A method of producing the guidewire according to claim 1, comprising:
forming the guidewire tip rear portion, the guidewire tip front portion, and/or the widening on a pre-machined wire; [¶42]
and fixedly altering a straight aligned length of the guidewire tip rear portion to form the flexing portion. [stamping / grinding of tapers in ¶42 is a form of ‘fixed altering’; more generally, use in tortuous anatomy per ¶2 in ¶¶37-45 is a form of deforming a portion such as 24 in Fig(s). 1 into a ‘curved’ length (i.e., curved during use)]
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds in view of Backman (US 5957865 A).
For claim 26, Reynolds teaches The method according to claim 25,
wherein the coiled member is configured with a first coil pitch along a chosen length thereof, and the connecting includes surrounding the flexing portion with the chosen coiled member length having the first coil pitch. [pitch in ¶72 for coil in Fig(s). 5-9]
Reynolds fails to teach a second coil pitch smaller than the first coil pitch along a remainder length thereof.
Backman teaches a vascular access device [abstract, Fig(s). 3] with a coil [52] which has two differing pitches with a second pitch smaller than a first pitch. [Fig(s). 3, col. 7 ll. 5-15]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the coil pitch of Reynolds to incorporate the differing pitches of Backman in order to provide the wire and coil strength without kinking or breaking. As motivated by Backman col. 7 ll. 5-15.
For claim 27, Reynolds teaches A device for forming a vascular access in a blood vessel via an access needle, [preferable embodiment of Fig(s). 1, consider also Fig(s). 14-17] comprising:
an elastic core member [10] comprising of a guidewire proximal segment [16] extending distally to a first narrowing, [18]
a guidewire intermediate segment [20] thinner than the guidewire proximal segment extending distally from the first narrowing to a second narrowing, [22]
a guidewire tip rear portion [24] thinner than the guidewire intermediate segment extending distally from the second narrowing to a widening, [26]
and a guidewire tip front portion [28] thicker than the guidewire tip rear portion extending distally from the widening;
and a cylindrical coiled member [46] extending between the first narrowing and the widening of the core member;
wherein the tip rear portion includes a flexing portion [portion or all of 24] configured to affect localized buckling and/or bending for inclining the tip front portion relative to the tip rear portion when the core member is axially compressed; [stiffness / flexibility (i.e., “bending”) control via tapering or use of a ‘ribbon’ intermediate section for a ‘tip’ portion of guidewire 10 is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Reynolds — see esp. ¶¶37-45]
wherein the coiled member is configured with a first coil pitch along a chosen length thereof surrounding the flexing portion. [pitch in ¶72 for coil in Fig(s). 5-9]
Reynolds fails to teach a second coil pitch smaller than the first coil pitch along a remainder length thereof.
Backman teaches a vascular access device [abstract, Fig(s). 3] with a coil [52] which has two differing pitches with a second pitch smaller than a first pitch. [Fig(s). 3, col. 7 ll. 5-15]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the coil pitch of Reynolds to incorporate the differing pitches of Backman in order to provide the wire and coil strength without kinking or breaking. As motivated by Backman col. 7 ll. 5-15.
For claim 28, Reynolds teaches The device according to claim 27,
wherein the flexing portion includes a curved length along which the core member is fixedly deviated laterally relatively to straight aligned portions of the core member proximally and distally adjacent to the curved length. [whole / portion of 24 in Fig(s). 1 would have a ‘curved’ length which is laterally deviated relative to proximal portions of 10 during navigation through tortuous anatomy as per ¶2 in view of ¶¶37-45]
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds in view of Ginster (US 20190030290 A1).
For claim(s) 34, Reynolds fails to teach a kit including a needle with the guidewire.
Ginster teaches a vascular access device which is a kit of a needle for a guidewire insertion. [Fig(s). 3-5]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the kit of Reynolds to include the needle of Ginster in order to safely permit access to patient anatomies and ensure therapeutic administration can occur. As motivated by Ginster ¶¶2-8.
Conclusion
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791
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