DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-12 in the reply filed on 7/8/2026 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/8/2026.
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.
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.
Claim(s) 1, 3-9, 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al U.S 2020/0390455.
Claim 1: Nguyen et al disclose a guidewire system (a treatment device 100) for traversing a patient's vasculature, the guidewire system comprising: a guidewire (shaft 170 function in a similar manner to a guidewire, see fig. 7, paragraph 598) comprising a tubular sidewall defining a lumen therein, the guidewire extending between a proximal portion and a distal portion, and wherein the distal portion of the guidewire is configured to be intravascularly delivered to a treatment site within a blood vessel (see paragraph 598); an elongate delivery member 120 slidably positioned within the lumen of the guidewire 170, the delivery member 120 having a proximal region and a distal region; and an interventional element140/140b carried by the distal region of the delivery member and configured to be positioned within the lumen of the guidewire in a collapsed configuration, wherein the delivery member 120 is configured to be pushed distally within the lumen to expel the interventional element from the lumen, thereby allowing the interventional element to expand to an expanded configuration (see abstract, paragraph 7).
Claims 3-4: Nguyen et al disclose further comprising a stiffening member fixed to the distal portion of the delivery member 120, proximal of the interventional element; wherein the stiffening member comprises a coil (see claims 10-11 of Nguyen).
Claims 5-6: Nguyen et al disclose further comprising a visualization
Member (2020, see paragraph 669) fixed to the distal portion of the delivery member, distal of the interventional element; wherein the visualization member comprises a coil (see fig. 20c, paragraph 681).
Claims 7-8: Nguyen et al disclose further comprising: a stiffening member (see claims 10-11 of Nguyen) fixed to the distal portion of the delivery member, proximal of the interventional element; and a visualization member 2020 fixed to the distal portion of the delivery member, distal of the interventional element; wherein one or both of the stiffening member and the visualization member comprise a coil (see paragraph 681).
Claims 9, 11-12: Nguyen et al disclose wherein at least a distal portion of
the sidewall of the guidewire comprises a laser-cut hypotube (see paragraphs 262,668); wherein the interventional element is an expandable stent comprising a plurality of interconnected struts (see paragraphs 263,605); wherein at least a distal portion of the sidewall of the guidewire includes a plurality of slits (groove wires 180/182, fig. 8a, paragraph 599).
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.
Claim(s) 2, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al.
Claims 2, 10: Nguyen et al disclose the invention substantially as claimed but is silent regarding wherein the guidewire has an outer diameter of 0.024 inches or less; or the distal region of the delivery member has an outer diameter than is smaller than an outer diameter of the proximal region. It would have been obvious to one having ordinary skill in the art before the claimed invention to modify the device of Nguyen et al by making the guidewire has an outer diameter of 0.024 inches or less; or the distal region of the delivery member has an outer diameter than is smaller than an outer diameter of the proximal region, since it has been held that where the only difference between the prior arts and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. Tec Syst., Inc., 725 F. 2d 1338, 220 USPQ 777 (Fed. Cir. 1984). In the instant case it appears there has been no critically placed on the specific the diameter of the guidwire or the diameter of the distal region of the delivery member, as evidence in applicant's specification at paragraph 6, wherein the ranges and values are given with no preference to one over another nor any evidence of unexpected results.
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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