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 Interpretation
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘guidewire lumen’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.”
Claim Objections
Claims 5, 6, 10, 11, 16 and 18 are objected to because of the following informalities:
Claim 5, line 2, please change “energy guide is emitted” to --energy guide is configured to be emitted--.
Claim 6, line 1, please change “plasma generation” to --plasma generator--.
Claim 10, line 2, please change “energy guide is emitted” to --energy guide is configured to be emitted--.
Claim 11, line 3, please change “guide distal end is emitted” to -- guide distal end is configured to be emitted--.
Claim 16, line 2, please change “generates” to --is configured to generate--.
Claim 18, lines 9-10, please change “being emitted” to --is configured to be emitted--.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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) 1-6, 9-10, and 13-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schultheis et al. (US 2024/0016545A1, “Schultheis”).
Regarding claims 1-5, 9, 10 and 17-19, Schultheis discloses a catheter system for treating a treatment site within or adjacent to a vessel. The catheter system includes an energy source (124, 224; [0054, 0101]; e.g. laser) that generates energy and a balloon (104, 804) coupled to a catheter shaft (110; [0043]). The balloon includes a balloon wall defining a balloon interior and is capable of retaining a catheter fluid within the balloon interior [abs, [0004, 0040-0044, 0050]. A plurality of energy guides (122, 822; e.g. optical fiber [0054]; Fig. 8) are capable of selectively receiving energy from the energy source. Each of the plurality of energy guides includes a guide distal end (822D; abs; [0004, 0053-0060, 0072, 0162]). A plurality of emitters is positioned within the balloon interior (Fig. 8) wherein each emitter includes the guide distal end of one of the plurality of energy guides and a corresponding plasma generator that is spaced apart from the guide distal end. The energy received by each of the plurality of energy guides is emitted from the guide distal end and impinges on the corresponding plasma generator (133, 833; [0162-0164]) so that plasma is generated adjacent to the plasma generator and in the catheter fluid retained within the balloon interior (abs; [0004, 0041, 0073, 0095-0097, 0162-0170]). The guide distal end of the energy guide and the plasma generator are positioned within the balloon interior (Fig. 8). A guidewire lumen (118, 1018; [0043]) has an outer surface that is grooved [0056]. At least the guide distal end of the energy guide is positioned adjacent to the outer surface of the guidewire lumen. A portion of the guidewire lumen encompasses a plasma generator that is positioned near the guide distal end of the energy guide, wherein sides of a groove formed into the outer surface of the guidewire lumen [0056; Fig. 8] encompasses a portion of the plasma generator. The plasma generator is capable of being positioned near the treatment site. The plasma generator is formed from a polymeric material, e.g. polyimide, nylon [0097, 0164].
Regarding claim 6, Schultheis discloses an acoustic (pressure) wave that is created by the plasma generator and is directed away from the plasma generator due to the angled face (833F; [0163]).
Regarding claims 13 and 14, Schultheis discloses that the plasma generator extends outwardly away from the grooved outer surface of the guidewire lumen and includes an angled face (833F) that is angled relative to the outer surface between approximately 5 and 45 degrees relative to a flat, perpendicular configuration so that the energy emitted from the guide distal end is capable of being emitted toward the angled face of the plasma generator and redirected toward the treatment site (Fig. 8).
Regarding claim 15, Schultheis discloses a system controller (126; [0086]) including a processor that is capable of controlling the energy source so that the energy from the energy source is selectively directed to the energy guide.
Regarding claims 16 and 17, Schultheis discloses that the energy source is a light source that generates pulses of light energy [0077-0080] and wherein the light source is a laser and the energy guide is an optical fiber [0054].
Regarding claim 20, Schultheis discloses a method for treating a treatment site within or adjacent to a vessel wall. Energy is generated with an energy source (abs;124, 224; [0054, 0101]; e.g. laser). The energy is selectively received from the energy source with an energy guide (abs;122, 822; e.g. optical fiber [0054]; Fig. 8). The energy guide includes a guide distal end (822D; abs; [0004, 0053-0060, 0072, 0162]). The energy received by the energy guide from the guide distal end is emitted (abs). At least the distal end of the energy guide is positioned adjacent to an outer surface of a guidewire lumen (118, 1018; Fig. 8). A portion of the guidewire lumen encompasses a plasma generator (133, 833; [0162-0164]) that is positioned near the guide distal end of the energy guide, wherein sides of a groove formed into the outer surface of the guidewire lumen [0056; Fig. 8] encompasses a portion of the plasma generator. The plasma generator is positioned near the treatment site [0042, 0044 and is formed from a polymeric material, e.g. polyimide, nylon [0097, 0164].
Allowable Subject Matter
The indicated allowability of claims 1-20 is withdrawn in view of the newly discovered reference(s) to Schultheis et al. (US 2024/0016545A1). Rejections based on the newly cited reference(s) are above.
Claims 7, 8, 11 and 12 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schultheis et al. (US 2023/0181254A1) discloses a plasma generator encompassed by a guidewire lumen having grooves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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