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 statements (IDS), submitted on 12/04/2023 and 01/03/2024, have been considered by the examiner.
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 10-13 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 10] The claim recites the limitation of “the one or more additional fluid delivery lumens” in the 3rd line of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if claim 10 was intended to depend directly from claim 9 (providing proper antecedent basis), or if a typographical error was made in the claim language. For purposes of examination, it is interpreted that claim 10 should depend directly from claim 9 (rather than claim 4).
[Claims 11-13] The claims are rejected based upon their dependency from claim 10.
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.
Claims 1-6 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oliver et al. (USPN 6,958,040).
[Claims 1 and 2] Oliver teaches a system (figure 1, item 10) for treating a vascular region (column 3, lines 11-13), the system comprising:
an elongate catheter shaft (figure 1, item 12) having a distal end region (figure 1, items 15/18);
wherein an inner lumen (figure 2, item 51), having a non-circular cross-sectional shape (figure 2), is formed in the elongate catheter shaft (figure 1, item 12);
wherein a fluid delivery lumen (figure 2, item 30) is formed in the elongate catheter shaft (figure 1, item 12) and positioned adjacent to the inner lumen (figure 2, item 51);
a treatment core (figure 3, item 34) disposed within (figure 8) the inner lumen (figure 2, item 51), the treatment core (figure 3, item 34) including one or more ultrasound transducers (figures 3 and 8, items 40/42) disposed adjacent to the distal end region (figure 1, items 15/18) of the elongate catheter shaft (figure 1, item 12) (column 10, lines 44-56), the one or more ultrasound transducers (figures 3 and 8, items 40/42) including a proximal-most ultrasound transducer (figures 3, 5, and 6; column 8, lines 6-16); and
wherein the fluid delivery lumen (figure 2, item 30) is adapted such that fluid passing through the fluid delivery lumen (figure 2, item 30) exits (via openings 58) the fluid delivery lumen (figure 2, item 30) at a position proximal to the proximal-most ultrasound transducer (figures 3, 5, and 6; column 8, lines 6-16) (figure 8; claims 6 and 13; “a fluid delivery lumen formed in the, tubular body, the fluid delivery lumen having at least one outlet proximal to the ultrasound radiating members”).
[Claim 3] Oliver teaches the limitations of claim 1, upon which claim 3 depends. In addition, Oliver discloses the inner lumen (figure 2, item 51) has a central treatment region (figure 8; space occupied by inner core 34) and one or more coolant regions (figure 8, item 44) disposed about the central treatment region (figure 8; space occupied by inner core 34) (figure 8; column 11, lines 39-56).
[Claims 4-6 and 9-13] Oliver teaches the limitations of claim 1, upon which claims 4-6 and 9-13 depend. Oliver further discloses one or more additional fluid delivery lumens (figure 2, item 30; Oliver teaches at least 3 fluid delivery lumens) that are formed in the elongate catheter shaft (figure 1, item 12) and are positioned adjacent to the inner lumen (figure 2, item 51); wherein each fluid delivery lumen (figure 2, item 30) includes an opening (figure 8, item 58) that is formed in a side wall of the elongate catheter shaft (figure 1, item 12) and in fluid communication (figure 8) with the one or more fluid delivery lumens (figure 2, item 30), such that the openings (figure 8, item 58) are side-facing/end-facing openings (figure 8; column 10, lines 57-65) (the examiner notes that the terms “side-facing” and “end-facing” have not been explicitly defined; as such, the openings taught by Oliver can be considered to be either “side-facing” or “end-facing,” depending on the perspective of the user).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7, 8, and 14-18, are rejected under 35 U.S.C. 103 as being unpatentable over Oliver et al. (USPN 6,958,040), in view of Anand et al. (PGPub 2019/0160254).
[Claims 7 and 8] Oliver teaches the limitations of claim 4, upon which claims 7 and 8 depend. Oliver does not specifically disclose the opening is a non-circular shape and/or oval.
However, Anand teaches a drug delivery system (figure 32a, item 500) comprising openings (figure 32a, item 504) for a fluid delivery lumen which are oval in shape (paragraph [0283]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the shape of the opening taught by Oliver, to be an oval shape, as taught by Anand, since it has been held that a change in the shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, Anand teaches such a shape can be useful in generating homogeneous directed infusion (Anand; paragraph [0283]).
[Claims 14 and 18] Oliver teaches an ultrasonic catheter system (figure 1, item 10), comprising:
a multi-lumen (figure 2) catheter shaft (figure 1, item 12) having a central lumen (figure 2, item 51) and a plurality of fluid delivery lumens (figure 2, item 30);
an ultrasound catheter core (figure 3, item 34) disposed within (figure 8) the central lumen (figure 2, item 51) (column 10, lines 44-56), the ultrasound catheter core (figure 3, item 34) including one or more ultrasound transducers (figures 3 and 8, items 40/42) including a proximal-most ultrasound transducer (figures 3, 5, and 6; column 8, lines 6-16);
wherein the central lumen (figure 2, item 51) is configured to allow for a cooling media to pass therethrough (via 44) when the ultrasound catheter core (figure 3, item 34) is disposed within the central lumen (figure 2, item 51) (figure 8; column 11, lines 39-56);
wherein the plurality of fluid delivery lumens (figure 2, item 30) include a first fluid delivery lumen (figure 8; any one of item 30 can be considered the “first” delivery lumen) that extends along the multi-lumen catheter shaft (figure 1, item 12) to a fluid delivery lumen distal end (at openings 58) that is disposed proximal of the proximal-most ultrasound transducer (figures 3, 5, and 6; column 8, lines 6-16) (figure 8; claims 6 and 13; “a fluid delivery lumen formed in the, tubular body, the fluid delivery lumen having at least one outlet proximal to the ultrasound radiating members”); and
wherein an opening (figure 8, item 58) is formed in the multi-lumen catheter shaft (figure 1, item 12) at the fluid delivery lumen distal end (at openings 58), the opening (figure 8, item 58) being in fluid communication (figure 8) with the first fluid delivery lumen (figure 8; any one of item 30 can be considered the “first” delivery lumen) (figure 8; column 10, lines 57-65).
Oliver does not specifically disclose the opening is a non-circular opening.
However, Anand teaches a drug delivery system (figure 32a, item 500) comprising openings (figure 32a, item 504) for a fluid delivery lumen which are oval in shape (paragraph [0283]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the shape of the opening taught by Oliver, to be an oval shape, as taught by Anand, since it has been held that a change in the shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, Anand teaches such a shape can be useful in generating homogeneous directed infusion (Anand; paragraph [0283]).
[Claims 15-17] Oliver and Anand teach the limitations of claim 14, upon which claims 15-17 depend. In addition, Oliver discloses the opening (figure 8, item 58) is formed in a side wall of the multi-lumen catheter shaft (figure 1, item 12) and is side-facing/end-facing (figure 8; column 10, lines 57-65) (the examiner notes that the terms “side-facing” and “end-facing” have not been explicitly defined; as such, the opening taught by Oliver can be considered to be either “side-facing” or “end-facing,” depending on the perspective of the user).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 13 of U.S. Patent No. 6,958,040. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 1 of the instant application can be found in claim 6 of the patent. The difference between claim 1 of the instant application and claim 6 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 6 of the patent is in effect a “species” of the "generic” invention of claim 1 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claim 6 of the patent, it is not patentably distinct from claim 6 of the patent.
Allowable Subject Matter
Claims 19 and 20 are allowed.
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to disclose or render obvious the method recited in independent claim 19.
The closest prior art of record is Oliver et al. (USPN 6,958,040) and Anand et al. (PGPub 2019/0160254).
The prior art of record fails to teach among all the limitations or render obvious a method comprising delivering a drug to a treatment site using an ultrasonic catheter system that includes a multi-lumen catheter shaft having a central lumen and a fluid delivery lumen, the fluid delivery lumen terminating at a distal end of the multi- lumen catheter shaft, and an ultrasound catheter core disposable within the central lumen, the ultrasound catheter core including a proximal-most ultrasound transducer, the method comprising:
advancing the multi-lumen catheter shaft to a treatment site;
advancing the ultrasound catheter core through the central lumen until the ultrasound catheter core reaches the distal end of the multi-lumen catheter shaft;
passing a drug solution through the fluid delivery lumen; and
activating the ultrasound catheter core.
Specifically, regarding independent claim 19, the prior art to Oliver and Anand, either alone or in combination, fails to disclose or render obvious the specific method, structural, and/or functional features as claimed;
wherein the method further comprises:
withdrawing the multi-lumen catheter shaft proximally such that the distal end of the multi-lumen catheter shaft is proximal of the proximal-most ultrasound transducer.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 03/18/2026