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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 1/16/2025 and 6/3/2026 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2-24 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.
Claim 2 (and thereby dependent claims 3-23) recites the limitation "the elongate body" in line 6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 22 recites the limitation "the conductive sheath" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 24 recites the limitation "the elongate body" in line 9. There is insufficient antecedent basis for this limitation in the claim. 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)(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) 2-3, 7-8, 10-11, 14-15, 17, 19-20 and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hakala et al. (US 9,433,428).
Hakala discloses (see Figs. 5A, 5C, 6A-6D, 12A-12C and 14A-14G) an angioplasty shock wave catheter and method comprising the following claim limitations:
(claim 2) A device (520, Fig. 5A) for generating shock waves comprising: an elongate member (602, Fig. 6A); a shock wave electrode assembly (526, Fig. 5A) comprising: a conductive member (608, Fig. 6A) mounted on the elongate member (602) (as shown in Fig. 6A), the conductive member (608) having a first edge portion (as shown in annotated Fig. 6C below) and a second edge portion (as shown in annotated Fig. 6C below) and extending from the first edge portion in a circumferential direction about the elongate body (602) to the second edge portion (as shown in annotated Fig. 6C below), and a conductor (610, Fig. 6A) positioned radially within the conductive member (608) and having an exposed portion (604, Fig. 6A) defining an electrode (as shown in Fig. 6A) that is spaced apart from the conductive member (608) by a gap (i.e., gap between electrodes 604/608 in Fig. 6A; col. 15, lines 59-col. 16, lines 9); and an enclosure (528, Fig. 5A) enclosing the shock wave electrode assembly (526) and being fillable with a conductive fluid (col. 12, lines 58-65);
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(claim 3) wherein the conductive member (608) is a first conductive member (as shown in annotated Fig. 6C below) and the electrode assembly comprises a second conductive member (as shown in annotated Fig. 6C below), the first conductive member and the second conductive member forming a sheath (608) that extends around the elongate member (602) (as shown in Fig. 6A);
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(claim 7) wherein the conductor is a first conductor (610) and the device comprises a second conductor (col. 16, lines 9-24; second inner electrode (i.e., similar to 610) expressly disclosed) positioned radially within the sheath (608) and having an exposed portion (604 of second conductor/wire 610) defining a second electrode (at 604 of second conductor/wire 610) that is spaced apart from the sheath (608) by a second gap (i.e., gap between second inner electrode 604/610 and second opening 609b, see Figs. 6A-6B);
(claim 8) wherein the first electrode (604) and the second electrode (i.e., second 604, not shown) are located at opposite ends of the sheath (608) (as shown in Fig. 6B at top end 609a and bottom end 609b; col. 16, lines 9-24; second electrode expressly disclosed circumferentially opposite the first electrode 604 shown in Fig. 6A);
(claim 10) wherein the first gap (i.e., between opening 609a and first electrode 604, as shown in Fig. 6A) and the second gap (i.e., between opening 609b and second electrode 604, as shown in Fig. 6B; col. 16, lines 9-24) are at diametrically opposite locations of the sheath (608) (as shown in Fig. 6B at 609a/609b; col. 16, lines 9-24; second electrode expressly disclosed circumferentially opposite the first electrode 604 shown in Fig. 6A);
(claim 11) wherein the first edge portion is adjacent to the second edge portion (as shown in annotated Fig. 6C under claim 2 above);
(claim 14) wherein the conductor is a first conductor (610), and the device comprises a second conductor (col. 16, lines 9-24; second inner electrode (i.e., similar to 610) expressly disclosed) positioned radially within the conductive member (608) and having an exposed portion (604 of second conductor/wire 610) defining a second electrode (at 604 of second conductor/wire 610) that is spaced apart from the conductive member (608) by a second gap (i.e., gap between second inner electrode 604/610 and second opening 609b, see Figs. 6A-6B);
(claim 15) wherein the first electrode (604) and the second electrode (i.e., second 604, not shown) are located at opposite ends of the conductive member (608) (as shown in Fig. 6B at top end 609a and bottom end 609b; col. 16, lines 9-24; second electrode expressly disclosed circumferentially opposite the first electrode 604 shown in Fig. 6A);
(claim 17) wherein the first gap (i.e., between opening 609a and first electrode 604, as shown in Fig. 6A) and the second gap (i.e., between opening 609b and second electrode 604, as shown in Fig. 6B; col. 16, lines 9-24) are at diametrically opposite locations of the conductive member (608) (as shown in Fig. 6B at 609a/609b; col. 16, lines 9-24; second electrode expressly disclosed circumferentially opposite the first electrode 604 shown in Fig. 6A);
(claim 19) comprising a plurality of shock wave electrode assemblies (554/556/558/560/562, Fig. 5C) spaced apart in a longitudinal direction of the elongate member (602) (as shown in Fig. 5C);
(claim 20) wherein the enclosure is a balloon (528, Fig. 5A; col. 12, lines 58-665);
(claim 22) wherein the electrode (604) is adjacent to an arcuate cut-out (609a) of the conductive sheath (608) (as shown in Fig. 6A);
(claim 23) A system comprising the device of claim 2 (see claim 2 mapping above) and voltage pulse generator for supplying voltage pulses to the shock wave electrode assembly (526) (col. 12, lines 58-64); and
(claim 24) A method for treating a calcified lesion in a lumen of a patient (see Abstract and claim 1; col. 1, lines 18-22; col. 12, lines 8-13), the method comprising: advancing a device (520, Fig. 5A) for generating shock waves into the lumen of the patient (see Abstract; col. 1, line 66-col. 2, line 2), the device comprising: an elongate member (602, Fig. 6A), a shock wave electrode assembly (526, Fig. 5A) comprising: a conductive member (608, Fig. 6A) mounted on the elongate member (602) (as shown in Fig. 6A), the conductive member (608) having a first edge portion (as shown in annotated Fig. 6C below) and a second edge portion (as shown in annotated Fig. 6C below) and extending from the first edge portion in a circumferential direction about the elongate body (602) to the second edge portion (as shown in annotated Fig. 6C below), and a conductor (610, Fig. 6A) positioned radially within the conductive member (608) and having an exposed portion (604, Fig. 6A) defining an electrode (as shown in Fig. 6A) that is spaced apart from the conductive member (608) by a gap (i.e., gap between electrodes 604/608 in Fig. 6A; col. 15, lines 59-col. 16, lines 9), and an enclosure (528, Fig. 5A) enclosing the shock wave electrode assembly (526); and treating the calcified lesion by applying a high voltage across the conductor and the conductive member to cause current to flow between the conductor (610) and the conductive member (608) to create a shock wave at the gap (i.e., gap between electrodes 604/608 in Fig. 6A; col. 4, lines 37-45; col. 15, lines 59-col. 16, lines 9).
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Allowable Subject Matter
Claims 4-6, 9, 12-13, 16-18 and 21 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. It is noted that claims 4-6, 9, 12-13, 16-18 and 21 each remains subject to 112 rejections, as set forth above, that must be resolved before any of these claims can be rewritten into independent form for allowance.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see Morgan (US 7,389,148).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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